Infants Ibuprofen
- Product NDC
- 0363-5100
- 11-digit product format
- 003635100
- Labeler code
- 0363
- Product ID
- 0363-5100_5d8f5b4b-811f-492f-a195-0205db857158
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Walgreens
- Application
- ANDA079058
- Marketing category
- ANDA
- Marketing start
- 2020-12-04
- Marketing end
- 2027-03-01
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Infants Ibuprofen
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 |
|---|
| 0363-5100-01 | Infants Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | | 4 |
| 0363-5100-01 | Infants Ibuprofen | 30 mL in 1 BOTTLE | SUSPENSION | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0363-5100 | INFANTS IBUPROFEN (IBUPROFEN) SUSPENSION [WALGREENS] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230105_3bbbe142-a00c-404b-a116-81ad730ea130.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 |
|---|
| 0363-5100-01 | 00363510001 | 1 BOTTLE in 1 CARTON (0363-5100-01) / 30 mL in 1 BOTTLE | 1 bottle | 2020-12-04 | 2027-03-01 | No | No | Current |