IBUPROFEN AND FAMOTIDINE
- Product NDC
- 43602-544
- 11-digit product format
- 436020544
- Labeler code
- 43602
- Product ID
- 43602-544_97d403fb-8a67-483d-8f9c-45dd16a31689
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen and famotidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascent Pharmaceuticals, Inc.
- Application
- ANDA216814
- Marketing category
- ANDA
- Marketing start
- 2022-10-06
- 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 |
DailyMed Product Concepts#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 43602-544-05 | 43602054405 | 500 TABLET in 1 BOTTLE (43602-544-05) | 500 tablet | 2022-10-06 | No | No | Historical |
| 43602-544-30 | 43602054430 | 30 TABLET in 1 BOTTLE (43602-544-30) | 30 tablet | 2022-10-06 | No | No | Historical |
| 43602-544-90 | 43602054490 | 90 TABLET in 1 BOTTLE (43602-544-90) | 90 tablet | 2022-10-06 | No | No | Historical |