Concentrated ibuprofen infants
- Product NDC
- 49035-635
- 11-digit product format
- 490350635
- Labeler code
- 49035
- Product ID
- 49035-635_ad449225-ed60-4c66-9fd6-34bef9a4b42e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION/ DROPS
- Route
- ORAL
- Labeler
- Wal-Mart Stores, Inc.
- Application
- ANDA210755
- Marketing category
- ANDA
- Marketing start
- 2019-06-20
- Substance
- IBUPROFEN
- Active strength
- 50 mg/1.25mL
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Concentrated ibuprofen infants
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 50 mg/1.25mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 204442 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49035-635-09 | Concentrated ibuprofen infants | 30 mL in 1 BOTTLE | SUSPENSION/ DROPS | 30 | | 3 |
| 49035-635-09 | Concentrated ibuprofen infants | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49035-635 | CONCENTRATED IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [WAL-MART STORES, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20220112_00b7fc71-8cf0-4c12-a479-146408f7f91b.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 |
|---|
| 49035-635-09 | 49035063509 | 1 BOTTLE in 1 CARTON (49035-635-09) / 30 mL in 1 BOTTLE | 1 bottle | 2019-06-20 | 0000-00-00 | No | No | Current |