Famotidine
- Product NDC
- 43063-533
- 11-digit product format
- 430630533
- Labeler code
- 43063
- Product ID
- 43063-533_41392bae-3ede-5191-e063-6294a90ac386
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA075511
- Marketing category
- ANDA
- Marketing start
- 2001-04-16
- Substance
- FAMOTIDINE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Famotidine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FAMOTIDINE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QZO15J2Z8 |
| Rxcui | 284245 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-533-30 | Famotidine | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FAMOTIDINE | ACTIVE INGREDIENT | 5QZO15J2Z8 | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| FAMOTIDINE | ACTIVE MOIETY | 5QZO15J2Z8 | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| INDIGOTINDISULFONATE SODIUM | INACTIVE INGREDIENT | D3741U8K7L | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-533 | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 21 | Current NDC, Legacy NDC, 1 package rows | 20241013_5798d282-ce83-49aa-bc33-13203f2b5285.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-533-30 | 43063053330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-533-30) | 2014-04-14 | 0000-00-00 | No | No | Current |