Over-the-counter drug · NDA
Aleve Headache Pain (Naproxen sodium) NDC 0280-0112
Naproxen sodium 220 mg/1 · Tablet · Oral · Bayer HealthCare LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0280-0112-01 | 00280011201 | 1 BOTTLE in 1 CARTON (0280-0112-01) / 175 TABLET in 1 BOTTLEMarketed from Mar 25, 2024 | |
| 0280-0112-02 | 00280011202 | 1 BOTTLE in 1 CARTON (0280-0112-02) / 24 TABLET in 1 BOTTLEMarketed from Mar 25, 2024 | |
| 0280-0112-03 | 00280011203 | 1 BOTTLE in 1 CARTON (0280-0112-03) / 50 TABLET in 1 BOTTLEMarketed from Mar 25, 2024 | |
| 0280-0112-04 | 00280011204 | 1 BOTTLE in 1 CARTON (0280-0112-04) / 90 TABLET in 1 BOTTLEMarketed from Mar 25, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Aleve Headache PainSuffix: Headache Pain
- Generic name (nonproprietary)
- naproxen sodium
- Active ingredients
- Naproxen sodium — 220 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bayer HealthCare LLC.NDC labeler code 0280
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020204
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 0280-0112_31baf777-c806-21ea-e063-6394a90abbd8SPL ID 31baf777-c806-21ea-e063-6394a90abbd8SPL set ID 31baf777-c805-21ea-e063-6394a90abbd8RxCUI 849574, 849728UNII 9TN87S3A3CUPC 0025866593527
- 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
N400280011201followed by a unit qualifier and the quantityPackage 00280-0112-01. 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 pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 0280-0112
- What is NDC 0280-0112?
- 0280-0112 is the product NDC for Aleve Headache Pain (naproxen sodium), Naproxen sodium 220 mg/1 tablet, listed with the FDA by Bayer HealthCare LLC.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Aleve Headache Pain (Naproxen sodium).
- What is the active ingredient?
- Naproxen sodium.
- Who is the labeler?
- Bayer HealthCare LLC., NDC labeler code 0280. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Aleve Headache Pain?
- 2 other product NDCs are listed under this name. See all Aleve Headache Pain NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Aleve Headache Pain products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Aleve Headache Painnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-8252 | 00280-8252-1000280-8252-24 |
| Aleve Headache Painnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Bayer HealthCare LLC | 0280-0041 | 00280-0041-0100280-0041-0200280-0041-03+2 more |
Other NDCs under NDA 020204
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 |
|---|---|---|---|---|
| Alevenaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-0113 |
| Alevenaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-6010 |
| Alevenaproxen sodium tablet | Naproxen sodium 220 mg/1 | TabletOral | Lil' Drug Store Products, Inc | 66715-5103 |
| Alevenaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Lil' Drug Store Products, Inc | 66715-6402 |
| Alevenaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Lil' Drug Store Products, Inc | 66715-6502 |
| Alevenaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Lil' Drug Store Products, Inc | 66715-9702 |
| Alevenaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Navajo Manufacturing Company Inc. | 67751-144 |
| Alevenaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | R J General Corporation | 70264-011 |
| Aleve Back and Muscle Painnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-0111 |
| Aleve Back and Muscle Painnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-6092 |
| Aleve Capletsnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-0114 |
| Aleve Capletsnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-6000 |
| Aleve Capletsnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Select Consumer Group | 85237-1832 |
| Aleve Caplets - Easy Open Arthritis Capnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-6050 |
| Aleve Caplets Easy Open Arthritisnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-0130 |
| Aleve Caplets Soft Grip Arthritisnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-0115 |
| Aleve Easy Open Arthritisnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-0131 |
| Aleve Easy Open Arthritis Capnaproxen sodium | Naproxen sodium 220 mg/1 | TabletOral | Bayer HealthCare LLC. | 0280-6060 |
| Aleve Gelcapsnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Bayer HealthCare LLC. | 0280-6020 |
| Aleve Gelcapsnaproxen sodium | Naproxen sodium 220 mg/1 | Tablet, CoatedOral | Bayer HealthCare LLC. | 0280-6070 |
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