Over-the-counter drug · ANDA
Childrens FLANAX ORAL (Ibuprofen) NDC 27854-777
Ibuprofen 100 mg/5mL · Suspension · Oral · Belmora LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27854-777-99 | 2785407779927854077799 | 1 BOTTLE in 1 CARTON (27854-777-99) / 120 mL in 1 BOTTLEMarketed from Jan 26, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Childrens FLANAX ORAL
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 100 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Belmora LLCNDC labeler code 27854
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209179
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 27854-777_1fb62f8c-355b-4760-90c8-a32f8b7dfde8SPL ID 1fb62f8c-355b-4760-90c8-a32f8b7dfde8SPL set ID 9b9318cb-3bc7-40ca-bf8a-7495d93869b3RxCUI 197803UNII WK2XYI10QM
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N427854077799followed by a unit qualifier and the quantityPackage 27854-0777-99. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily: • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache • reduces fever
Excerpt only. Read the full label for complete information.
About NDC 27854-777
- What is NDC 27854-777?
- 27854-777 is the product NDC for Childrens FLANAX ORAL (ibuprofen), Ibuprofen 100 mg/5mL suspension, listed with the FDA by Belmora LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens FLANAX ORAL (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Belmora LLC, NDC labeler code 27854. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Childrens FLANAX ORAL?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 209179
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Randob Labs., Ltd. | 52412-911 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | KROGER COMPANY | 30142-281 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Aurohealth LLC | 58602-002 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Aurohealth LLC | 58602-003 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Aurohealth LLC | 58602-008 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | BluePoint Laboratories | 68001-521 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Better Living Brands, LLC | 21130-216 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | 7-Eleven | 10202-150 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | WALGREEN CO. | 0363-8901 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | 7-Eleven | 10202-711 |
| Childrens Ibuprofenibuprofen | Ibuprofen 100 mg/5mL | SuspensionOral | Chalkboard Health | 79395-003 |