IBU
- Product NDC
- 50436-4604
- 11-digit product format
- 504364604
- Labeler code
- 50436
- Product ID
- 50436-4604_97aeb9d2-7f81-4db3-b2d3-d238af2adac7
- 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
- 400 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 |
|---|---|---|---|---|---|
| 50436-4604-0 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-0e26-a910-e053-dadaa90a0b85 | IBU ™ Tablets |
| 50436-4604-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-0e26-a910-e053-dadaa90a0b85 | IBU ™ Tablets |
| 50436-4604-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-0e26-a910-e053-dadaa90a0b85 | IBU ™ Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-4604-0 | IBU | 12 in 1 BOTTLE | TABLET | 12 | 5 | |
| 50436-4604-1 | IBU | 30 in 1 BOTTLE | TABLET | 30 | 5 | |
| 50436-4604-6 | IBU | 40 in 1 BOTTLE | TABLET | 40 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-4604-1 | EA - Each | 50436-4604 | 6a29ee16-651b-45b3-ba33-3728c8d3d6df | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-4604 | IBU (IBUPROFEN) TABLET [UNIT DOSE SERVICES] | 5 | Legacy NDC, 3 package rows | 20180110_bf56640a-3f81-4166-8f0f-f45a26e6545b.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 206905 | Ibu 400 MG Oral Tablet | PSN | bf56640a-3f81-4166-8f0f-f45a26e6545b | 5 |
| 206917 | Ibu 800 MG Oral Tablet | PSN | bf56640a-3f81-4166-8f0f-f45a26e6545b | 5 |
| 197805 | ibuprofen 400 MG Oral Tablet | PSN | bf56640a-3f81-4166-8f0f-f45a26e6545b | 5 |
| 197807 | ibuprofen 800 MG Oral Tablet | PSN | bf56640a-3f81-4166-8f0f-f45a26e6545b | 5 |
| 206905 | ibuprofen 400 MG Oral Tablet [Ibu] | SBD | bf56640a-3f81-4166-8f0f-f45a26e6545b | 5 |
| 206917 | ibuprofen 800 MG Oral Tablet [Ibu] | SBD | bf56640a-3f81-4166-8f0f-f45a26e6545b | 5 |
| 197805 | ibuprofen 400 MG Oral Tablet | SCD | bf56640a-3f81-4166-8f0f-f45a26e6545b | 5 |
| 197807 | ibuprofen 800 MG Oral Tablet | SCD | bf56640a-3f81-4166-8f0f-f45a26e6545b | 5 |
| 206905 | Ibu 400 MG Oral Tablet | SY | bf56640a-3f81-4166-8f0f-f45a26e6545b | 5 |
| 206917 | Ibu 800 MG Oral Tablet | SY | bf56640a-3f81-4166-8f0f-f45a26e6545b | 5 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-4604-0 | 50436460400 | 12 in 1 BOTTLE | Historical |
| 50436-4604-1 | 50436460401 | 30 in 1 BOTTLE | Historical |
| 50436-4604-6 | 50436460406 | 40 in 1 BOTTLE | Historical |