Famotidine
- Product NDC
- 0615-4582
- 11-digit product format
- 006154582
- Labeler code
- 0615
- Product ID
- 0615-4582_b936bdb0-9b96-4f47-9f5d-53f363a6a2ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA075511
- Marketing category
- ANDA
- Marketing start
- 2010-04-30
- Marketing end
- 0000-00-00
- Substance
- FAMOTIDINE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FAMOTIDINE | ACTIVE INGREDIENT | 5QZO15J2Z8 | FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| FAMOTIDINE | ACTIVE MOIETY | 5QZO15J2Z8 | FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-4582 | FAMOTIDINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 10 | Legacy NDC | 20241207_8be0d6bb-172c-46c5-b887-12c0faa6db9b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-4582-05 | 00615458205 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-4582-05) | 2010-04-30 | 0000-00-00 | No | No | Current |
| 0615-4582-39 | 00615458239 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-4582-39) | 2010-04-30 | 0000-00-00 | No | No | Current |