Over-the-counter drug · NDA
Aleve PM NDC 0280-1200
diphenhydramine hydrochloride and naproxen sodium · Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 · Tablet, Film coated · Oral · Bayer HealthCare LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0280-1200-01 | 00280120001 | 1 BOTTLE in 1 CARTON (0280-1200-01) / 120 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 9, 2014 | |
| 0280-1200-02 | 00280120002 | 2 TABLET, FILM COATED in 1 POUCH (0280-1200-02)Marketed from Sep 9, 2014 | |
| 0280-1200-03 | 00280120003 | 160 TABLET, FILM COATED in 1 BOTTLE (0280-1200-03)Marketed from Sep 9, 2014 | |
| 0280-1200-04 | 00280120004 | 1 BOTTLE in 1 CARTON (0280-1200-04) / 40 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 9, 2014 | |
| 0280-1200-05 | 00280120005 | 80 TABLET, FILM COATED in 1 BOTTLE (0280-1200-05)Marketed from Sep 9, 2014 | |
| 0280-1200-08 | 00280120008 | 1 BOTTLE in 1 CARTON (0280-1200-08) / 250 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 1, 2021 | |
| 0280-1200-20 | 00280120020 | 1 BOTTLE in 1 CARTON (0280-1200-20) / 20 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 9, 2014 | |
| 0280-1200-40 | 00280120040 | 1 BOTTLE in 1 CARTON (0280-1200-40) / 40 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 9, 2014 | |
| 0280-1200-80 | 00280120080 | 1 BOTTLE in 1 CARTON (0280-1200-80) / 80 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 9, 2014 |
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 PM
- Generic name (nonproprietary)
- diphenhydramine hydrochloride and naproxen sodium
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1Naproxen sodium — 220 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bayer HealthCare LLC.
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205352
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0280-1200_45265ccc-d985-a6ad-e063-6394a90a75b7SPL ID 45265ccc-d985-a6ad-e063-6394a90a75b7SPL set ID 82891458-ab0d-459a-8602-dcebd22c3010RxCUI 1550957, 1550963UNII TC2D6JAD40, 9TN87S3A3CUPC 0025866591882
- Pharmacologic class
- Histamine-1 Receptor Antagonist; 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
N400280120001followed by a unit qualifier and the quantityPackage 00280-1200-01. 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 for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
Excerpt only. Read the full label for complete information.