Over-the-counter drug · ANDA
Naproxen Sodium and Diphenhydramine HCl (Naproxen sodium and diphenhydramine) NDC 69238-1422
Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1422-2 | 6923814220269238142202 | 1 BOTTLE in 1 CARTON (69238-1422-2) / 20 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 23, 2018 | |
| 69238-1422-4 | 6923814220469238142204 | 1 BOTTLE in 1 CARTON (69238-1422-4) / 40 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 23, 2018 | |
| 69238-1422-6 | 6923814220669238142206 | 1 BOTTLE in 1 CARTON (69238-1422-6) / 160 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 23, 2018 | |
| 69238-1422-8 | 6923814220869238142208 | 1 BOTTLE in 1 CARTON (69238-1422-8) / 80 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 23, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Naproxen Sodium and Diphenhydramine HCl
- Generic name (nonproprietary)
- naproxen sodium and diphenhydramine
- Active ingredients
- Naproxen sodium — 220 mg/1Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 69238
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209726
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69238-1422_b9db3e35-7654-4bf3-8536-38f56b8780c7SPL ID b9db3e35-7654-4bf3-8536-38f56b8780c7SPL set ID caca14cf-95f2-4c60-8bba-2154b8f353a3RxCUI 1550957UNII 9TN87S3A3C, TC2D6JAD40UPC 0369238142266
- 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
N469238142202followed by a unit qualifier and the quantityPackage 69238-1422-02. 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.
About NDC 69238-1422
- What is NDC 69238-1422?
- 69238-1422 is the product NDC for Naproxen Sodium and Diphenhydramine HCl, Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naproxen Sodium and Diphenhydramine HCl (Naproxen Sodium and Diphenhydramine).
- What is the active ingredient?
- Naproxen sodium, Diphenhydramine hydrochloride.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Naproxen Sodium and Diphenhydramine HCl?
- 2 other product NDCs are listed under this name. See all Naproxen Sodium and Diphenhydramine HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Naproxen Sodium and Diphenhydramine HCl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Naproxen Sodium and Diphenhydramine HCL | Diphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1 | TabletOral | TARGET CORPORATION | 11673-819 | 11673-0819-08 |
| Naproxen Sodium and Diphenhydramine HCl | Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Granules India Ltd | 62207-814 | 62207-0814-3862207-0814-3962207-0814-47+1 more |
Other NDCs under ANDA 209726
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 PMnaproxen sodium | Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Strategic Sourcing Services LLC | 70677-0064 |