Famotidine
- Product NDC
- 43063-086
- 11-digit product format
- 430630086
- Labeler code
- 43063
- Product ID
- 43063-086_e6625b83-f6c7-fb78-e053-2995a90ad53a
- 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
- 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 Product Concepts#
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.] | 5 | |
| FAMOTIDINE | ACTIVE MOIETY | 5QZO15J2Z8 | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-086 | FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 21 | Legacy NDC | 20241012_015bebfb-55a7-4b44-a94d-b032231058b4.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-086-06 | 43063008606 | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-086-06) | 2011-02-11 | 0000-00-00 | No | No | Current |