Ibuprofen
- Product NDC
- 49035-438
- 11-digit product format
- 490350438
- Labeler code
- 49035
- Product ID
- 49035-438_5466b324-a1b4-4cf9-a4f0-006124254bba
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Wal-Mart Stores Inc
- Application
- ANDA075139
- Marketing category
- ANDA
- Marketing start
- 2004-03-11
- Marketing end
- 2028-02-29
- Substance
- IBUPROFEN
- Active strength
- 200 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Brand name suffix
- Dye-Free
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 310965 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49035-438-12 | IbuprofenDye-Free | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 16 |
| 49035-438-12 | IbuprofenDye-Free | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 16 |
| 49035-438-90 | IbuprofenDye-Free | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] | 1 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49035-438 | IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] | 14 | Current NDC, Legacy NDC, 3 package rows | 20240913_23cb5001-6aeb-434a-b2e8-aaf8bbab9dc6.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 |
|---|
| 49035-438-12 | 49035043812 | 1 BOTTLE in 1 CARTON (49035-438-12) > 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2004-03-11 | 2021-05-16 | No | No | Current |
| 49035-438-90 | 49035043890 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49035-438-90) | | 2004-03-11 | 2028-02-29 | No | No | Current |