FAMOTIDINE
- Product NDC
- 42571-433
- 11-digit product format
- 425710433
- Labeler code
- 42571
- Product ID
- 42571-433_3b0aa4df-ee1f-e4e3-e063-6394a90a4c66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FAMOTIDINE
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Micro Labs Limited
- Application
- ANDA217842
- Marketing category
- ANDA
- Marketing start
- 2023-12-01
- Substance
- FAMOTIDINE
- Active strength
- 40 mg/5mL
- 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 | 40 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QZO15J2Z8 |
| Rxcui | 310274 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42571-433-45 | FAMOTIDINE | 50 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 50 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-433 | FAMOTIDINE POWDER, FOR SUSPENSION [MICRO LABS LIMITED] | 1 | Current NDC, 1 package rows | 20231201_1756ab7d-05c4-4726-8f72-4e8363440968.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42571-433-45 | 42571043345 | 50 mL in 1 BOTTLE (42571-433-45) | 50 ml | 2023-12-01 | No | No | Current |