FAMOTIDINE
- Product NDC
- 70518-4574
- 11-digit product format
- 705184574
- Labeler code
- 70518
- Product ID
- 70518-4574_4e7dedbd-fe91-4c60-e063-6394a90aec7c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FAMOTIDINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA215630
- Marketing category
- ANDA
- Marketing start
- 2026-02-16
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FAMOTIDINE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FAMOTIDINE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QZO15J2Z8 |
| Rxcui | 310273 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4574-0 | FAMOTIDINE | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | | 5 |
| 70518-4574-1 | FAMOTIDINE | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 5 |
| 70518-4574-2 | FAMOTIDINE | 80 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 80 | | 5 |
| 70518-4574-3 | FAMOTIDINE | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4574-0 | 70518457400 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4574-0) | 2026-02-16 | No | No | Historical |
| 70518-4574-1 | 70518457401 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4574-1) | 2026-03-04 | No | No | Historical |
| 70518-4574-2 | 70518457402 | 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4574-2) | 2026-03-10 | No | No | Historical |
| 70518-4574-3 | 70518457403 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4574-3) | 2026-04-02 | No | No | Historical |