Over-the-counter drug · ANDA
Flanax Pain Reliever/Fever Reducer (Naproxen sodium) NDC 27854-700
Naproxen sodium 220 mg/1 · Tablet, Film coated · Oral · Belmora LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27854-700-01 | 2785407000127854070001 | 1 BOTTLE in 1 CARTON (27854-700-01) / 24 TABLET, FILM COATED in 1 BOTTLEMarketed from May 15, 2020 | |
| 27854-700-10 | 2785407001027854070010 | 1 BOTTLE in 1 CARTON (27854-700-10) / 10 TABLET, FILM COATED in 1 BOTTLEMarketed from May 15, 2020 | |
| 27854-700-99 | 2785407009927854070099 | 1 BOTTLE in 1 CARTON (27854-700-99) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from May 15, 2020 |
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)
- Flanax Pain Reliever/Fever Reducer
- Generic name (nonproprietary)
- naproxen sodium
- Active ingredients
- Naproxen sodium — 220 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Belmora LLCNDC labeler code 27854
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205497
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 27854-700_4215c852-11ed-4b06-b132-3674265078e3SPL ID 4215c852-11ed-4b06-b132-3674265078e3SPL set ID a93e4966-9dd3-40ba-b7d6-6ca8fef229c6RxCUI 849574UNII 9TN87S3A3C
- 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
N427854070001followed by a unit qualifier and the quantityPackage 27854-0700-01. 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 pain due to: ■ headache ■ muscular aches ■ toothache ■ the common cold ■ backache ■ menstrual cramps ■ minor pain of arthritis ■ temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 27854-700
- What is NDC 27854-700?
- 27854-700 is the product NDC for Flanax Pain Reliever/Fever Reducer, Naproxen sodium 220 mg/1 tablet, film coated, listed with the FDA by Belmora LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Flanax Pain Reliever/Fever Reducer (Naproxen sodium).
- What is the active ingredient?
- Naproxen sodium.
- 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 Flanax Pain Reliever/Fever Reducer?
- 2 other product NDCs are listed under this name. See all Flanax Pain Reliever/Fever Reducer NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Flanax Pain Reliever/Fever Reducer products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Flanax Pain Reliever/Fever Reducernaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Navajo Manufacturing Company Inc. | 67751-125 | 67751-0125-01 |
| Flanax Pain Reliever/Fever reducernaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Belmora LLC | 27854-505 | 27854-0505-0127854-0505-02 |
Other NDCs under ANDA 205497
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 |
|---|---|---|---|---|
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | WALMART INC. | 79903-232 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | WALMART INC. | 79903-231 |
| Amazon Basic Care Naproxen Sodiumnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-366 |
| Naproxen Sodium HEADACHE PAINnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-737 |
| Naproxen Sodium HEADACHE PAINnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-735 |
| Naproxen Sodium BACK AND MUSCLE PAINnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-736 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-738 |
| Naproxen Sodium BACK AND MUSCLE PAINnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-739 |
| Ana-Dent PAIN RELIEFnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Belmora LLC | 27854-701 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-819 |
| Naproxen Sodium | Naproxen sodium 220 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-845 |