Famotidine
- Product NDC
- 68645-140
- 11-digit product format
- 686450140
- Labeler code
- 68645
- Product ID
- 68645-140_efb917fa-13a7-635d-e053-2a95a90aeb20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Legacy Pharmaceutical Packaging, LLC
- Application
- ANDA075511
- Marketing category
- ANDA
- Marketing start
- 2009-10-26
- 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 [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| FAMOTIDINE | ACTIVE MOIETY | 5QZO15J2Z8 | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| INDIGOTINDISULFONATE SODIUM | INACTIVE INGREDIENT | D3741U8K7L | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| POLYETHYLENE GLYCOL 3000 | INACTIVE INGREDIENT | SA1B764746 | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | FAMOTIDINE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68645-140 | FAMOTIDINE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 20 | Legacy NDC | 20250313_f3abe0c2-2029-4d89-b413-606a421491e4.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68645-140-59 | 68645014059 | 60 TABLET, FILM COATED in 1 BOTTLE (68645-140-59) | 2009-10-26 | 0000-00-00 | No | No | Current |