Ibuprofen
- Product NDC
- 43063-352
- 11-digit product format
- 430630352
- Labeler code
- 43063
- Product ID
- 43063-352_e6880353-4127-4466-e053-2995a90a19a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078558
- Marketing category
- ANDA
- Marketing start
- 2009-11-23
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 600 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-352 | IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 21 | Legacy NDC | 20250302_a5388667-4d0d-4a62-836b-188664452d04.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-352-06 | 43063035206 | 6 TABLET in 1 BOTTLE, PLASTIC (43063-352-06) | 6 tablet | 2010-09-17 | 0000-00-00 | No | No | Current |