Ibuprofen
- Product NDC
- 68071-2903
- 11-digit product format
- 680712903
- Labeler code
- 68071
- Product ID
- 68071-2903_efbb5e80-b38f-7fed-e053-2995a90a5a90
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA213794
- Marketing category
- ANDA
- Marketing start
- 2020-05-08
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 800 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 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 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 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 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-2903-1 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8528-d83d-e063-dadaa90ab31f | Ibuprofen Tablets, USP Rx only |
| 68071-2903-4 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8528-d83d-e063-dadaa90ab31f | Ibuprofen Tablets, USP Rx only |
| 68071-2903-5 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8528-d83d-e063-dadaa90ab31f | Ibuprofen Tablets, USP Rx only |
| 68071-2903-6 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8528-d83d-e063-dadaa90ab31f | Ibuprofen Tablets, USP Rx only |
| 68071-2903-7 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8528-d83d-e063-dadaa90ab31f | Ibuprofen Tablets, USP Rx only |
| 68071-2903-9 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8528-d83d-e063-dadaa90ab31f | Ibuprofen Tablets, USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-2903-1 | Ibuprofen | 21 in 1 BOTTLE | TABLET | 21 | 7 | |
| 68071-2903-4 | Ibuprofen | 40 in 1 BOTTLE | TABLET | 40 | 7 | |
| 68071-2903-5 | Ibuprofen | 15 in 1 BOTTLE | TABLET | 15 | 7 | |
| 68071-2903-6 | Ibuprofen | 60 in 1 BOTTLE | TABLET | 60 | 7 | |
| 68071-2903-7 | Ibuprofen | 12 in 1 BOTTLE | TABLET | 12 | 7 | |
| 68071-2903-9 | Ibuprofen | 90 in 1 BOTTLE | TABLET | 90 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-2903 | IBUPROFEN TABLET [NUCARE PHARMACEUTICALS,INC.] | 7 | Legacy NDC, 6 package rows | 20230613_efbb5bca-1796-76d1-e053-2995a90a0bc8.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197807 | ibuprofen 800 MG Oral Tablet | PSN | efbb5bca-1796-76d1-e053-2995a90a0bc8 | 7 |
| 197807 | ibuprofen 800 MG Oral Tablet | SCD | efbb5bca-1796-76d1-e053-2995a90a0bc8 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-2903-1 | 68071290301 | 21 in 1 BOTTLE | Historical | |||||
| 68071-2903-4 | 68071290304 | 40 in 1 BOTTLE | Historical | |||||
| 68071-2903-5 | 68071290305 | 15 TABLET in 1 BOTTLE (68071-2903-5) | 15 tablet | 2022-12-13 | 0000-00-00 | No | No | Current |
| 68071-2903-6 | 68071290306 | 60 in 1 BOTTLE | Historical | |||||
| 68071-2903-7 | 68071290307 | 12 in 1 BOTTLE | Historical | |||||
| 68071-2903-9 | 68071290309 | 90 in 1 BOTTLE | Historical |