CHILDRENS IBUPROFEN
- Product NDC
- 52412-911
- 11-digit product format
- 524120911
- Labeler code
- 52412
- Product ID
- 52412-911_d97115c6-f191-4faa-8e74-3e8817e4a48f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Randob Labs., Ltd.
- Application
- ANDA209179
- Marketing category
- ANDA
- Marketing start
- 2023-07-15
- Substance
- IBUPROFEN
- Active strength
- 100 mg/5mL
- 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
- CHILDRENS IBUPROFEN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197803 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52412-911-04 | CHILDRENS IBUPROFEN | 120 mL in 1 BOTTLE | SUSPENSION | 120 | | 2 |
| 52412-911-04 | CHILDRENS IBUPROFEN | 1 in 1 CARTON | SUSPENSION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52412-911 | CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [RANDOB LABS., LTD.] | 1 | Current NDC, 2 package rows | 20230722_50d6bf9d-ae37-4af3-bfeb-cc0abf8cb094.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 52412-911-04 | 52412091104 | 1 BOTTLE in 1 CARTON (52412-911-04) / 120 mL in 1 BOTTLE | 1 bottle | 2023-07-15 | No | No | Current |