Famotidine
- Product NDC
- 58602-829
- 11-digit product format
- 586020829
- Labeler code
- 58602
- Product ID
- 58602-829_d4587b3e-852f-49b4-8237-1cd6e20e063a
- 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
- 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
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 |
|---|
| 58602-829-21 | Famotidine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 9 |
| 58602-829-21 | Famotidine | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 9 |
| 58602-829-34 | Famotidine | 200 in 1 BOTTLE | TABLET, FILM COATED | 200 | | 9 |
| 58602-829-34 | Famotidine | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 9 |
| 58602-829-50 | Famotidine | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 9 |
| 58602-829-50 | Famotidine | 85 in 1 BOTTLE | TABLET, FILM COATED | 85 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-829 | FAMOTIDINE TABLET, FILM COATED [AUROHEALTH LLC] | 9 | Current NDC, Legacy NDC, 6 package rows | 20250425_5b161f25-c578-4ff4-a931-ff3a1e681c50.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 |
|---|
| 58602-829-21 | 58602082921 | 1 BOTTLE in 1 CARTON (58602-829-21) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2016-04-26 | 0000-00-00 | No | No | Current |
| 58602-829-34 | 58602082934 | 1 BOTTLE in 1 CARTON (58602-829-34) / 200 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-03-25 | 0000-00-00 | No | No | Current |
| 58602-829-50 | 58602082950 | 1 BOTTLE in 1 CARTON (58602-829-50) / 85 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-03-02 | 0000-00-00 | No | No | Current |