IBU
- Product NDC
- 53002-3010
- 11-digit product format
- 530023010
- Labeler code
- 53002
- Product ID
- 53002-3010_792c9efc-44b8-4395-8348-f0af5d5f3ba2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- 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
- 2021-12-31
- 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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-3010-1 | IBU | 10 in 1 BOTTLE | TABLET | 10 | 9 | |
| 53002-3010-2 | IBU | 15 in 1 BOTTLE | TABLET | 15 | 9 | |
| 53002-3010-3 | IBU | 20 in 1 BOTTLE | TABLET | 20 | 9 | |
| 53002-3010-4 | IBU | 30 in 1 BOTTLE | TABLET | 30 | 9 | |
| 53002-3010-5 | IBU | 50 in 1 BOTTLE | TABLET | 50 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-3010 | IBU (IBUPROFEN) TABLET [RPK PHARMACEUTICALS, INC.] | 9 | Legacy NDC, 5 package rows | 20230609_405074f3-9c1a-46cd-889e-76ec8966a556.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 206913 | Ibu 600 MG Oral Tablet | PSN | 405074f3-9c1a-46cd-889e-76ec8966a556 | 9 |
| 206917 | Ibu 800 MG Oral Tablet | PSN | 405074f3-9c1a-46cd-889e-76ec8966a556 | 9 |
| 197806 | ibuprofen 600 MG Oral Tablet | PSN | 405074f3-9c1a-46cd-889e-76ec8966a556 | 9 |
| 197807 | ibuprofen 800 MG Oral Tablet | PSN | 405074f3-9c1a-46cd-889e-76ec8966a556 | 9 |
| 206913 | ibuprofen 600 MG Oral Tablet [Ibu] | SBD | 405074f3-9c1a-46cd-889e-76ec8966a556 | 9 |
| 206917 | ibuprofen 800 MG Oral Tablet [Ibu] | SBD | 405074f3-9c1a-46cd-889e-76ec8966a556 | 9 |
| 197806 | ibuprofen 600 MG Oral Tablet | SCD | 405074f3-9c1a-46cd-889e-76ec8966a556 | 9 |
| 197807 | ibuprofen 800 MG Oral Tablet | SCD | 405074f3-9c1a-46cd-889e-76ec8966a556 | 9 |
| 206913 | Ibu 600 MG Oral Tablet | SY | 405074f3-9c1a-46cd-889e-76ec8966a556 | 9 |
| 206917 | Ibu 800 MG Oral Tablet | SY | 405074f3-9c1a-46cd-889e-76ec8966a556 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-3010-1 | 53002301001 | 10 TABLET in 1 BOTTLE (53002-3010-1) | 10 tablet | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-3010-2 | 53002301002 | 15 TABLET in 1 BOTTLE (53002-3010-2) | 15 tablet | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-3010-3 | 53002301003 | 20 TABLET in 1 BOTTLE (53002-3010-3) | 20 tablet | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-3010-4 | 53002301004 | 30 TABLET in 1 BOTTLE (53002-3010-4) | 30 tablet | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-3010-5 | 53002301005 | 50 TABLET in 1 BOTTLE (53002-3010-5) | 50 tablet | 2017-10-01 | 0000-00-00 | No | No | Current |