FAMOTIDINE
- Product NDC
- 72865-214
- 11-digit product format
- 728650214
- Labeler code
- 72865
- Product ID
- 72865-214_b37fe9a5-6465-4518-823d-5d369a4c7793
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- XLCare Pharmaceuticals, Inc.
- Application
- ANDA215689
- Marketing category
- ANDA
- Marketing start
- 2021-10-15
- 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 | 284245, 310273 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72865-214-01 | FAMOTIDINE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 72865-214-05 | FAMOTIDINE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
| 72865-214-18 | FAMOTIDINE | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 1 |
| 72865-214-30 | FAMOTIDINE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72865-214 | FAMOTIDINE TABLET, FILM COATED [XLCARE PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 4 package rows | 20211216_7b550cf9-221f-4f28-ba99-414ad7d5612f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72865-214-01 | 72865021401 | 100 TABLET, FILM COATED in 1 BOTTLE (72865-214-01) | 2021-10-15 | 0000-00-00 | No | No | Current |
| 72865-214-05 | 72865021405 | 500 TABLET, FILM COATED in 1 BOTTLE (72865-214-05) | 2021-10-15 | 0000-00-00 | No | No | Current |
| 72865-214-18 | 72865021418 | 180 TABLET, FILM COATED in 1 BOTTLE (72865-214-18) | 2021-10-15 | 0000-00-00 | No | No | Current |
| 72865-214-30 | 72865021430 | 30 TABLET, FILM COATED in 1 BOTTLE (72865-214-30) | 2021-10-15 | 0000-00-00 | No | No | Current |