Ibuprofen
- Product NDC
- 10544-613
- 11-digit product format
- 105440613
- Labeler code
- 10544
- Product ID
- 10544-613_10457e1d-06ae-7071-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA078558
- Marketing category
- ANDA
- Marketing start
- 2010-05-17
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 800 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10544-613-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-869b-f424-e053-dadaa90a57ce | Ibuprofen Tablets, USP RX Only |
| 10544-613-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-869b-f424-e053-dadaa90a57ce | Ibuprofen Tablets, USP RX Only |
| 10544-613-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-869b-f424-e053-dadaa90a57ce | Ibuprofen Tablets, USP RX Only |
| 10544-613-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-869b-f424-e053-dadaa90a57ce | Ibuprofen Tablets, USP RX Only |
| 10544-613-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-869b-f424-e053-dadaa90a57ce | Ibuprofen Tablets, USP RX Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10544-613-02 | Ibuprofen | 120 in 1 BOTTLE | TABLET | 120 | 3 | |
| 10544-613-15 | Ibuprofen | 15 in 1 BOTTLE | TABLET | 15 | 3 | |
| 10544-613-20 | Ibuprofen | 20 in 1 BOTTLE | TABLET | 20 | 3 | |
| 10544-613-30 | Ibuprofen | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 10544-613-90 | Ibuprofen | 90 in 1 BOTTLE | TABLET | 90 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10544-613-15 | EA - Each | 10544-613 | 6e8fa7af-3856-45f4-af91-68f9359a7708 | 1 | 2015-05-05 |
| 10544-613-30 | EA - Each | 10544-613 | 8564e81d-8209-4786-b92a-1f4967555818 | 1 | 2015-02-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197807 | ibuprofen 800 MG Oral Tablet | PSN | 05507c46-5292-43f1-bff7-5e1ee659ca3d | 3 |
| 197807 | ibuprofen 800 MG Oral Tablet | SCD | 05507c46-5292-43f1-bff7-5e1ee659ca3d | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 10544-613-02 | 10544061302 | 120 in 1 BOTTLE | Historical |
| 10544-613-15 | 10544061315 | 15 in 1 BOTTLE | Historical |
| 10544-613-20 | 10544061320 | 20 in 1 BOTTLE | Historical |
| 10544-613-30 | 10544061330 | 30 in 1 BOTTLE | Historical |
| 10544-613-90 | 10544061390 | 90 in 1 BOTTLE | Historical |