| Drug NDC: | 65162-668 |
| 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: | Prenatal Plus |
| 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: | Vitamin A Acetate, .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Oxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Amneal Pharmaceuticals Llc |
| 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: | .ALPHA.-TOCOPHEROL ACETATE, DL- - 22 mg/1 ASCORBIC ACID - 120 mg/1 BETA CAROTENE - 920 [iU]/1 CALCIUM CARBONATE - 200 mg/1 CHOLECALCIFEROL - 400 [iU]/1 CUPRIC OXIDE - 2 mg/1 CYANOCOBALAMIN - 12 ug/1 FERROUS FUMARATE - 27 mg/1 FOLIC ACID - 1 mg/1 NIACINAMIDE - 20 mg/1 Load more... PYRIDOXINE HYDROCHLORIDE - 10 mg/1 RIBOFLAVIN - 3 mg/1 THIAMINE MONONITRATE - 1.84 mg/1 VITAMIN A ACETATE - 3080 [iU]/1 ZINC OXIDE - 25 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 Category: | UNAPPROVED DRUG OTHER |
| 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: | 02 Dec, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 01 Jan, 2026 |
| 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. | |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Amneal Pharmaceuticals LLC |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. | |
| Original Packager: | Yes |
| Whether or not the drug has been repackaged for distribution. | |
| NUI: | N0000193618 M0001797 M0022797 N0000175952 M0022794 N0000175951 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | WR1WPI7EW8 PQ6CK8PD0R 01YAE03M7J H0G9379FGK 1C6V77QF41 V1XJQ704R4 P6YC3EG204 R5L488RY0Q 935E97BOY8 25X51I8RD4 Load more... 68Y4CF58BV TLM2976OFR 8K0I04919X 3LE3D9D6OY SOI2LOH54Z |
| 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 EPC: | Vitamin C [EPC] Vitamin D [EPC] Vitamin B12 [EPC] |
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. | |
| Pharmacologic Class CS: | Ascorbic Acid [CS] Vitamin D [CS] Vitamin B 12 [CS] |
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. | |
| Pharmacologic Class: | Analogs/Derivatives [Chemical/Ingredient] Ascorbic Acid [CS] Blood Coagulation Factor [EPC] Calcium [CS] Cations Divalent [CS] Increased Coagulation Factor Activity [PE] Vitamin A [CS] Vitamin A [EPC] Vitamin B 12 [CS] Vitamin B 6 [Chemical/Ingredient] Vitamin B12 [EPC] Vitamin B6 Analog [EPC] Vitamin C [EPC] Vitamin D [CS] Vitamin D [EPC] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 65162-668-10 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65162-668-10) | 02 Dec, 2009 | N/A | No |
| 65162-668-50 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65162-668-50) | 02 Dec, 2009 | 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. | ||||
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