Ibuprofen
- Product NDC
- 51407-839
- 11-digit product format
- 514070839
- Labeler code
- 51407
- Product ID
- 51407-839_43fabc4f-9b49-0848-e063-6294a90a4916
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA075682
- Marketing category
- ANDA
- Marketing start
- 2025-09-26
- Substance
- IBUPROFEN
- Active strength
- 400 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], 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
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| IBUPROFEN | 400 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | WK2XYI10QM |
| Rxcui | 197805, 197806, 197807 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 16cde546-8deb-4df2-a072-dab5566ede95 | Product name | 1 | 20231003 |
| f6d1b8d7-3bd1-4248-eddd-b60565c88015 | Product name | 4 | 20230808 |
| 874f4e63-49d2-5150-5d77-052172814ebd | Product name | 6 | 20230105 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 997601aa-bb5f-6971-6b90-a21132c12c7b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51407-839-01 | Ibuprofen | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 51407-839-05 | Ibuprofen | 500 in 1 BOTTLE | TABLET | 500 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51407-839-01 | EA - Each | 51407-839 | c3345420-584a-4d02-80c7-31a73dd4f413 | 1 | 2025-11-13 |
| 51407-839-05 | EA - Each | 51407-839 | cd46ebbd-2ece-464f-b1b6-6d661deaf0dc | 1 | 2025-11-13 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197805 | ibuprofen 400 MG Oral Tablet | PSN | 3ff501eb-5ae3-8824-e063-6394a90ac58e | 3 |
| 197806 | ibuprofen 600 MG Oral Tablet | PSN | 3ff501eb-5ae3-8824-e063-6394a90ac58e | 3 |
| 197807 | ibuprofen 800 MG Oral Tablet | PSN | 3ff501eb-5ae3-8824-e063-6394a90ac58e | 3 |
| 197805 | ibuprofen 400 MG Oral Tablet | SCD | 3ff501eb-5ae3-8824-e063-6394a90ac58e | 3 |
| 197806 | ibuprofen 600 MG Oral Tablet | SCD | 3ff501eb-5ae3-8824-e063-6394a90ac58e | 3 |
| 197807 | ibuprofen 800 MG Oral Tablet | SCD | 3ff501eb-5ae3-8824-e063-6394a90ac58e | 3 |
| 197805 | ibuprofen 400 MG Oral Tablet | PSN | 4522cb9e-4999-c455-e063-6294a90a294f | 1 |
| 197805 | ibuprofen 400 MG Oral Tablet | SCD | 4522cb9e-4999-c455-e063-6294a90a294f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51407-839-01 | 51407083901 | 100 TABLET in 1 BOTTLE (51407-839-01) | 100 tablet | 2025-09-26 | No | No | Historical |
| 51407-839-05 | 51407083905 | 500 TABLET in 1 BOTTLE (51407-839-05) | 500 tablet | 2025-09-26 | No | No | Historical |