Famotidine
- Product NDC
- 58602-828
- 11-digit product format
- 586020828
- Labeler code
- 58602
- Product ID
- 58602-828_01351d50-0222-4f6c-93cc-66b2afb98669
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA206531
- Marketing category
- ANDA
- Marketing start
- 2016-04-26
- Substance
- FAMOTIDINE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QZO15J2Z8 |
| Rxcui | 199047 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58602-828-19 | Famotidine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
| 58602-828-19 | Famotidine | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-828 | FAMOTIDINE TABLET, FILM COATED [AUROHEALTH LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250321_27ecf5c1-202a-44cf-94f9-d7fefa027e1e.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 |
|---|
| 58602-828-19 | 58602082819 | 1 BOTTLE in 1 CARTON (58602-828-19) / 90 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2016-04-26 | 0000-00-00 | No | No | Current |