Famotidine
- Product NDC
- 55315-435
- 11-digit product format
- 553150435
- Labeler code
- 55315
- Product ID
- 55315-435_8dd0ce14-1eb8-4c4a-9f4a-2671fabfa7c0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Fred's, Inc.
- Application
- ANDA206531
- Marketing category
- ANDA
- Marketing start
- 2016-04-26
- 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
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A206531-001 | FAMOTIDINE | FAMOTIDINE | 10MG | TABLET / ORAL | | | 2016-04-26 |
| A206531-002 | FAMOTIDINE | FAMOTIDINE | 20MG | TABLET / ORAL | | | 2016-04-26 |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings Allergy alert: Do not use if you are allergic to famotidine or other acid reducers
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Famotidine
- Listing expiration
- 2026-12-31
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 |
|---|
| 55315-435-53 | Famotidine | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 5 |
| 55315-435-53 | Famotidine | 25 in 1 BOTTLE | TABLET, FILM COATED | 25 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55315-435 | FAMOTIDINE TABLET, FILM COATED [FRED'S, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250426_81b105a1-01fe-51d7-e053-2991aa0a71bc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55315-435-53 | 55315043553 | 1 BOTTLE in 1 CARTON (55315-435-53) / 25 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2016-04-26 | 0000-00-00 | No | No | Current |