IBU
- Product NDC
- 50436-4605
- 11-digit product format
- 504364605
- Labeler code
- 50436
- Product ID
- 50436-4605_3084b568-a1f8-461b-97ad-00be615eac2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA075682
- Marketing category
- ANDA
- Marketing start
- 2008-11-20
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 600 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 |
|---|---|---|---|---|---|
| 50436-4605-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-0df3-a910-e053-dadaa90a0b85 | IBU ™ Tablets |
| 50436-4605-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-0df3-a910-e053-dadaa90a0b85 | IBU ™ Tablets |
| 50436-4605-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-0df3-a910-e053-dadaa90a0b85 | IBU ™ Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-4605-1 | IBU | 30 in 1 BOTTLE | TABLET | 30 | 9 | |
| 50436-4605-2 | IBU | 60 in 1 BOTTLE | TABLET | 60 | 9 | |
| 50436-4605-3 | IBU | 90 in 1 BOTTLE | TABLET | 90 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-4605-1 | EA - Each | 50436-4605 | 53074a96-4d0d-45e2-bceb-7389d57e6266 | 1 | 2015-10-02 |
| 50436-4605-2 | EA - Each | 50436-4605 | 18adaf67-032d-4de5-ba79-5440f1551aaa | 1 | 2015-10-02 |
| 50436-4605-3 | EA - Each | 50436-4605 | 081c12f0-0fdd-4947-a9d8-20b90191a02e | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-4605 | IBU (IBUPROFEN) TABLET [UNIT DOSE SERVICES] | 9 | Legacy NDC, 3 package rows | 20171121_f2a61c07-e9b7-4d18-acd5-d0ddbc5ce1b2.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 206913 | Ibu 600 MG Oral Tablet | PSN | f2a61c07-e9b7-4d18-acd5-d0ddbc5ce1b2 | 9 |
| 197806 | ibuprofen 600 MG Oral Tablet | PSN | f2a61c07-e9b7-4d18-acd5-d0ddbc5ce1b2 | 9 |
| 206913 | ibuprofen 600 MG Oral Tablet [Ibu] | SBD | f2a61c07-e9b7-4d18-acd5-d0ddbc5ce1b2 | 9 |
| 197806 | ibuprofen 600 MG Oral Tablet | SCD | f2a61c07-e9b7-4d18-acd5-d0ddbc5ce1b2 | 9 |
| 206913 | Ibu 600 MG Oral Tablet | SY | f2a61c07-e9b7-4d18-acd5-d0ddbc5ce1b2 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-4605-1 | 50436460501 | 30 in 1 BOTTLE | Historical |
| 50436-4605-2 | 50436460502 | 60 in 1 BOTTLE | Historical |
| 50436-4605-3 | 50436460503 | 90 in 1 BOTTLE | Historical |