Famotidine
- Product NDC
- 63868-583
- 11-digit product format
- 638680583
- Labeler code
- 63868
- Product ID
- 63868-583_cf8df4a2-be86-9900-a859-a08b841f6a53
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chain Drug Marketing Association INC
- Application
- ANDA077367
- Marketing category
- ANDA
- Marketing start
- 2020-12-01
- 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, 310273 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63868-583-30 | Famotidine | 1 in 1 CARTON | TABLET | 1 | | 6 |
| 63868-583-30 | Famotidine | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63868-583 | FAMOTIDINE TABLET [CHAIN DRUG MARKETING ASSOCIATION INC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241024_1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a.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 |
|---|
| 63868-583-30 | 63868058330 | 1 BOTTLE in 1 CARTON (63868-583-30) / 30 TABLET in 1 BOTTLE | 1 bottle | 2020-12-01 | 0000-00-00 | No | No | Current |