Ibuprofen and Famotidine
- Product NDC
- 72578-214
- 11-digit product format
- 725780214
- Labeler code
- 72578
- Product ID
- 72578-214_d0498b4c-d60a-4a93-b151-d3bc4658787a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen and Famotidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Viona Pharmaceuticals Inc
- Application
- ANDA218684
- Marketing category
- ANDA
- Marketing start
- 2025-06-01
- Substance
- FAMOTIDINE; IBUPROFEN
- Active strength
- 26.6; 800 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen and Famotidine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FAMOTIDINE | 26.6 mg/1 |
| IBUPROFEN | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QZO15J2Z8, WK2XYI10QM |
| Rxcui | 1100066 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72578-214-16 | Ibuprofen and Famotidine | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72578-214-16 | 72578021416 | 90 TABLET in 1 BOTTLE (72578-214-16) | 90 tablet | 2025-06-01 | No | No | Historical |