Ibuprofen
- Product NDC
- 50436-4606
- 11-digit product format
- 504364606
- Labeler code
- 50436
- Product ID
- 50436-4606_e751abdb-c833-49a1-b3a6-7d481af0757f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA078558
- Marketing category
- ANDA
- Marketing start
- 2009-11-23
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 800 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|---|---|---|---|---|
| 50436-4606-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-22f4-a910-e053-dadaa90a0b85 | Ibuprofen Tablets, USP RX Only |
| 50436-4606-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-22f4-a910-e053-dadaa90a0b85 | Ibuprofen Tablets, USP RX Only |
| 50436-4606-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-22f4-a910-e053-dadaa90a0b85 | Ibuprofen Tablets, USP RX Only |
| 50436-4606-5 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-22f4-a910-e053-dadaa90a0b85 | Ibuprofen Tablets, USP RX Only |
| 50436-4606-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-22f4-a910-e053-dadaa90a0b85 | Ibuprofen Tablets, USP RX Only |
| 50436-4606-7 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-22f4-a910-e053-dadaa90a0b85 | Ibuprofen Tablets, USP RX Only |
| 50436-4606-8 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-22f4-a910-e053-dadaa90a0b85 | Ibuprofen Tablets, USP RX Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-4606-1 | Ibuprofen | 30 in 1 BOTTLE | TABLET | 30 | 13 | |
| 50436-4606-2 | Ibuprofen | 60 in 1 BOTTLE | TABLET | 60 | 13 | |
| 50436-4606-3 | Ibuprofen | 90 in 1 BOTTLE | TABLET | 90 | 13 | |
| 50436-4606-5 | Ibuprofen | 12 in 1 BOTTLE | TABLET | 12 | 13 | |
| 50436-4606-6 | Ibuprofen | 40 in 1 BOTTLE | TABLET | 40 | 13 | |
| 50436-4606-7 | Ibuprofen | 10 in 1 BOTTLE | TABLET | 10 | 13 | |
| 50436-4606-8 | Ibuprofen | 15 in 1 BOTTLE | TABLET | 15 | 13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-4606 | IBUPROFEN TABLET [UNIT DOSE SERVICES] | 13 | Legacy NDC, 7 package rows | 20171113_69fbfd9b-5a75-486c-bf29-b63745cdfc7d.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197807 | ibuprofen 800 MG Oral Tablet | PSN | 69fbfd9b-5a75-486c-bf29-b63745cdfc7d | 13 |
| 197807 | ibuprofen 800 MG Oral Tablet | SCD | 69fbfd9b-5a75-486c-bf29-b63745cdfc7d | 13 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-4606-1 | 50436460601 | 30 in 1 BOTTLE | Historical |
| 50436-4606-2 | 50436460602 | 60 in 1 BOTTLE | Historical |
| 50436-4606-3 | 50436460603 | 90 in 1 BOTTLE | Historical |
| 50436-4606-5 | 50436460605 | 12 in 1 BOTTLE | Historical |
| 50436-4606-6 | 50436460606 | 40 in 1 BOTTLE | Historical |
| 50436-4606-7 | 50436460607 | 10 in 1 BOTTLE | Historical |
| 50436-4606-8 | 50436460608 | 15 in 1 BOTTLE | Historical |