Childrens FLANAX ORAL
- Product NDC
- 27854-777
- 11-digit product format
- 278540777
- Labeler code
- 27854
- Product ID
- 27854-777_1fb62f8c-355b-4760-90c8-a32f8b7dfde8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Belmora LLC
- Application
- ANDA209179
- Marketing category
- ANDA
- Marketing start
- 2024-01-26
- 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 FLANAX ORAL
- 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 |
|---|
| 27854-777-99 | Childrens FLANAX ORAL | 120 mL in 1 BOTTLE | SUSPENSION | 120 | | 1 |
| 27854-777-99 | Childrens FLANAX ORAL | 1 in 1 CARTON | SUSPENSION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27854-777 | CHILDRENS FLANAX ORAL (IBUPROFEN) SUSPENSION [BELMORA LLC] | 1 | Current NDC, 2 package rows | 20240323_9b9318cb-3bc7-40ca-bf8a-7495d93869b3.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 |
|---|
| 27854-777-99 | 27854077799 | 1 BOTTLE in 1 CARTON (27854-777-99) / 120 mL in 1 BOTTLE | 1 bottle | 2024-01-26 | No | No | Current |