IBU
- Product NDC
- 53002-3370
- 11-digit product format
- 530023370
- Labeler code
- 53002
- Product ID
- 53002-3370_6c48a385-0433-4060-bc76-01b454e81a7c
- 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
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-3370-1 | IBU | 15 in 1 BOTTLE | TABLET | 15 | | 7 |
| 53002-3370-3 | IBU | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
| 53002-3370-5 | IBU | 50 in 1 BOTTLE | TABLET | 50 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-3370 | IBU (IBUPROFEN) TABLET [RPK PHARMACEUTICALS, INC.] | 7 | Legacy NDC, 3 package rows | 20230609_e25dd2e8-a1d4-4098-9b8a-c20a635969d4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-3370-1 | 53002337001 | 15 TABLET in 1 BOTTLE (53002-3370-1) | 15 tablet | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-3370-3 | 53002337003 | 30 TABLET in 1 BOTTLE (53002-3370-3) | 30 tablet | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-3370-5 | 53002337005 | 50 TABLET in 1 BOTTLE (53002-3370-5) | 50 tablet | 2017-10-01 | 0000-00-00 | No | No | Current |