topcare acid reducer
- Product NDC
- 76162-300
- 11-digit product format
- 761620300
- Labeler code
- 76162
- Product ID
- 76162-300_8a5a69da-3a67-4ecc-97d1-39ffea001485
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA077351
- Marketing category
- ANDA
- Marketing start
- 2022-09-25
- 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
- topcare acid reducer
- 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 |
|---|
| 76162-300-71 | topcare acid reducer | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 2 |
| 76162-300-71 | topcare acid reducer | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76162-300 | TOPCARE ACID REDUCER (FAMOTIDINE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221018_7824fdab-cdd5-457d-9b14-b82b19ea9529.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 |
|---|
| 76162-300-71 | 76162030071 | 1 BOTTLE in 1 CARTON (76162-300-71) / 50 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2022-09-25 | 0000-00-00 | No | No | Current |