Dimethyl Fumarate
Zydus Lifesciences Limited
Human Prescription Drug
NDC 70771-1531Dimethyl Fumarate is a human prescription drug labeled by 'Zydus Lifesciences Limited'. National Drug Code (NDC) number for Dimethyl Fumarate is 70771-1531. This drug is available in dosage form of Capsule, Delayed Release. The names of the active, medicinal ingredients in Dimethyl Fumarate drug includes Dimethyl Fumarate - 240 mg/1 . The currest status of Dimethyl Fumarate drug is Active.
Drug Information:
| Drug NDC: | 70771-1531 |
| 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: | Dimethyl Fumarate |
| 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: | Dimethyl Fumarate |
| 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: | Capsule, Delayed Release |
| 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: | DIMETHYL FUMARATE - 240 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: | 28 Sep, 2020 |
| 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: | ANDA210538 |
| 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: | 1373483
1373491
1373497
|
| 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: | FO2303MNI2
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 70771-1531-6 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70771-1531-6) | 28 Sep, 2020 | N/A | No |
| 70771-1531-8 | 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70771-1531-8) | 28 Sep, 2020 | 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:
Dimethyl fumarate dimethyl fumarate dimethyl fumarate dimethyl fumarate dimethyl fumarate monomethyl fumarate ammonia cellulose, microcrystalline croscarmellose sodium d&c yellow no. 10 fd&c blue no. 1 fd&c red no. 40 ferric oxide red ferric oxide yellow ferrosoferric oxide gelatin glyceryl mono and dicaprylocaprate magnesium stearate methacrylic acid - ethyl acrylate copolymer (1:1) type a methacrylic acid - methyl methacrylate copolymer (1:1) polysorbate 80 potassium hydroxide povidone k30 propylene glycol shellac silicon dioxide sodium lauryl sulfate talc titanium dioxide triethyl citrate opaque light green cap opaque white body capsule 1204 dimethyl fumarate dimethyl fumarate dimethyl fumarate monomethyl fumarate ammonia cellulose, microcrystalline croscarmellose sodium d&c yellow no. 10 fd&c blue no. 1 fd&c red no. 40 ferric oxide red ferric oxide yellow ferrosoferric oxide gelatin glyceryl mono and dicaprylocaprate magnesium stearate methacrylic acid - ethyl acrylate copolymer (1:1) type a methacrylic acid - methyl methacrylate copolymer (1:1) polysorbate 80 potassium hydroxide povidone k30 propylene glycol shellac silicon dioxide sodium lauryl sulfate talc titanium dioxide triethyl citrate opaque light green cap opaque light green body capsule 1205 dimethyl fumarate dimethyl fumarate dimethyl fumarate monomethyl fumarate ammonia caprylic/capric mono/di-glycerides cellulose, microcrystalline croscarmellose sodium d&c yellow no. 10 fd&c blue no. 1 fd&c red no. 40 ferric oxide red ferric oxide yellow ferrosoferric oxide gelatin magnesium stearate methacrylic acid - methyl methacrylate copolymer (1:1) methacrylic acid and ethyl acrylate copolymer polysorbate 80 potassium hydroxide povidone k30 propylene glycol shellac silicon dioxide sodium lauryl sulfate talc titanium dioxide triethyl citrate opaque light green cap opaque white body capsule 1204 dimethyl fumarate dimethyl fumarate dimethyl fumarate monomethyl fumarate ammonia caprylic/capric mono/di-glycerides cellulose, microcrystalline croscarmellose sodium d&c yellow no. 10 fd&c blue no. 1 fd&c red no. 40 ferric oxide red ferric oxide yellow ferrosoferric oxide gelatin magnesium stearate methacrylic acid - methyl methacrylate copolymer (1:1) methacrylic acid and ethyl acrylate copolymer polysorbate 80 potassium hydroxide povidone k30 propylene glycol shellac silicon dioxide sodium lauryl sulfate talc titanium dioxide triethyl citrate opaque light green cap opaque light green body capsule 1205
Package Label Principal Display Panel:
Package label.principal display panel ndc 70771-1532-3 30-day starter pack carton label dimethyl fumarate delayed-release capsules 120 mg starter dose: 14 capsules 240 mg regular dose: 46 capsules rx only ndc 70771-1530-7 dimethyl fumarate delayed-release capsules, 120 mg 14 capsules rx only ndc 70771-1531-6 dimethyl fumarate delayed-release capsules, 240 mg 60 capsules rx only label label label