Amlodipine And Atorvastatin
Zydus Lifesciences Limited
Human Prescription Drug
NDC 70771-1466Amlodipine And Atorvastatin is a human prescription drug labeled by 'Zydus Lifesciences Limited'. National Drug Code (NDC) number for Amlodipine And Atorvastatin is 70771-1466. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Amlodipine And Atorvastatin drug includes Amlodipine Besylate - 10 mg/1 Atorvastatin Calcium Trihydrate - 40 mg/1 . The currest status of Amlodipine And Atorvastatin drug is Active.
Drug Information:
| Drug NDC: | 70771-1466 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Amlodipine And Atorvastatin |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Amlodipine And Atorvastatin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Zydus Lifesciences Limited |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film Coated |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | AMLODIPINE BESYLATE - 10 mg/1
ATORVASTATIN CALCIUM TRIHYDRATE - 40 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 30 May, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA207762 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Zydus Lifesciences Limited
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 404011
404013
597967
597971
597974
597977
597980
597984
597987
597990
Load more...597993
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 864V2Q084H
48A5M73Z4Q
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Calcium Channel Antagonists [MoA]
Calcium Channel Blocker [EPC]
Cytochrome P450 3A Inhibitors [MoA]
Dihydropyridine Calcium Channel Blocker [EPC]
Dihydropyridines [CS]
HMG-CoA Reductase Inhibitor [EPC]
Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 70771-1466-1 | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1466-1) | 30 May, 2019 | N/A | No |
| 70771-1466-3 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1466-3) | 30 May, 2019 | N/A | No |
| 70771-1466-4 | 10 BLISTER PACK in 1 CARTON (70771-1466-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 30 May, 2019 | N/A | No |
| 70771-1466-9 | 90 TABLET, FILM COATED in 1 BOTTLE (70771-1466-9) | 30 May, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Amlodipine and atorvastatin amlodipine and atorvastatin amlodipine besylate amlodipine atorvastatin calcium trihydrate atorvastatin calcium carbonate cellulose, microcrystalline croscarmellose sodium fd&c blue no. 2 hydroxypropyl cellulose, unspecified hypromelloses magnesium stearate polysorbate 80 silicon dioxide starch, corn talc titanium dioxide blue biconvex f14 amlodipine and atorvastatin amlodipine and atorvastatin amlodipine besylate amlodipine atorvastatin calcium trihydrate atorvastatin calcium carbonate cellulose, microcrystalline croscarmellose sodium hydroxypropyl cellulose, unspecified hypromelloses magnesium stearate polysorbate 80 silicon dioxide starch, corn talc titanium dioxide white to off-white round 424 amlodipine and atorvastatin amlodipine and atorvastatin amlodipine besylate amlodipine atorvastatin calcium trihydrate atorvastatin calcium carbonate cellulose, microcrystalline croscarmellose sodium hydroxypropyl cellulose, unspecified hypromelloses magnesium stearate polysorbate 80 silicon dioxide starch, corn talc titanium dioxide white to off-white round 425 amlodipine and atorvastatin amlodipine and atorvastatin amlodipine besylate amlodipine atorvastatin calcium trihydrate atorvastatin calcium carbonate cellulose, microcrystalline croscarmellose sodium hydroxypropyl cellulose, unspecified hypromelloses magnesium stearate polysorbate 80 silicon dioxide starch, corn talc titanium dioxide white to off-white round 426 amlodipine and atorvastatin amlodipine and atorvastatin amlodipine besylate amlodipine atorvastatin calcium trihydrate atorvastatin calcium carbonate cellulose, microcrystalline croscarmellose sodium hydroxypropyl cellulose, unspecified hypromelloses magnesium stearate polysorbate 80 silicon dioxide starch, corn talc titanium dioxide white to off-white oval 427 amlodipine and atorvastatin amlodipine and atorvastatin amlodipine besylate amlodipine atorvastatin calcium trihydrate atorvastatin calcium carbonate cellulose, microcrystalline croscarmellose sodium hydroxypropyl cellulose, unspecified hypromelloses magnesium stearate polysorbate 80 silicon dioxide starch, corn talc titanium dioxide white to off-white oval 428 amlodipine and atorvastatin amlodipine and atorvastatin amlodipine besylate amlodipine atorvastatin calcium trihydrate atorvastatin calcium carbonate cellulose, microcrystalline croscarmellose sodium hydroxypropyl cellulose, unspecified hypromelloses magnesium stearate polysorbate 80 silicon dioxide starch, corn talc titanium dioxide white to off-white oval 429 amlodipine and atorvastatin amlodipine and atorvastatin amlodipine besylate amlodipine atorvastatin calcium trihydrate atorvastatin calcium carbonate cellulose, microcrystalline croscarmellose sodium hydroxypropyl cellulose, unspecified hypromelloses magnesium stearate polysorbate 80 silicon dioxide starch, corn talc titanium dioxide white to off-white oval 430 amlodipine and atorvastatin amlodipine and atorvastatin amlodipine besylate amlodipine atorvastatin calcium trihydrate atorvastatin calcium carbonate cellulose, microcrystalline croscarmellose sodium fd&c blue no. 2 hydroxypropyl cellulose, unspecified hypromelloses magnesium stearate polysorbate 80 silicon dioxide starch, corn talc titanium dioxide light blue to blue o 431 amlodipine and atorvastatin amlodipine and atorvastatin amlodipine besylate amlodipine atorvastatin calcium trihydrate atorvastatin calcium carbonate cellulose, microcrystalline croscarmellose sodium fd&c blue no. 2 hydroxypropyl cellulose, unspecified hypromelloses magnesium stearate polysorbate 80 silicon dioxide starch, corn talc titanium dioxide light blue to blue oval 432 amlodipine and atorvastatin amlodipine and atorvastatin amlodipine besylate amlodipine atorvastatin calcium trihydrate atorvastatin calcium carbonate cellulose, microcrystalline croscarmellose sodium fd&c blue no. 2 hydroxypropyl cellulose, unspecified hypromelloses magnesium stearate polysorbate 80 silicon dioxide starch, corn talc titanium dioxide light blue to blue oval 433
Package Label Principal Display Panel:
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