Over-the-counter drug · ANDA
Night Time Sleep Aid (Doxylamine succinate) NDC 80513-371
Doxylamine succinate 25 mg/1 · Tablet · Oral · Advanced Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80513-371-25 | 8051303712580513037125 | 225 TABLET in 1 BOTTLE (80513-371-25)Marketed from Aug 29, 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)
- Night Time Sleep Aid
- Generic name (nonproprietary)
- doxylamine succinate
- Active ingredients
- Doxylamine succinate — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advanced Rx LLCNDC labeler code 80513
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040564
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 80513-371_2f0e58dc-121b-d508-e063-6294a90a34ffSPL ID 2f0e58dc-121b-d508-e063-6294a90a34ffSPL set ID db8b730a-1553-4682-96bf-41e670ed0347RxCUI 1101446UNII V9BI9B5YI2UPC 0380513000897
- Pharmacologic class
- Antihistamine
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
N480513037125followed by a unit qualifier and the quantityPackage 80513-0371-25. 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)
Use helps to reduce difficulty in falling asleep
Excerpt only. Read the full label for complete information.
About NDC 80513-371
- What is NDC 80513-371?
- 80513-371 is the product NDC for Night Time Sleep Aid (doxylamine succinate), Doxylamine succinate 25 mg/1 tablet, listed with the FDA by Advanced Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Night Time Sleep Aid (Doxylamine Succinate).
- What is the active ingredient?
- Doxylamine succinate.
- Who is the labeler?
- Advanced Rx LLC, NDC labeler code 80513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Night Time Sleep Aid?
- 4 other product NDCs are listed under this name. See all Night Time Sleep Aid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Night Time Sleep Aid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Night Time Sleep-Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Advanced Rx LLC | 80513-383 | 80513-0383-22 |
| Night Time Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-114 | 55910-0114-12 |
| Night Time Sleep-Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | Discount Drug Mart | 53943-522 | 53943-0522-2553943-0522-28 |
| Night Time Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | HyVee Inc | 42507-959 | 42507-0959-40 |
Other NDCs under ANDA 040564
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 |
|---|---|---|---|---|
| Nocto Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Belmora LLC | 27854-375 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Better Living Brands, LLC | 21130-986 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Strategic Sourcing Services LLC | 70677-1129 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Wal-Mart Stores Inc | 49035-968 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | H E B | 37808-886 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | United Natural Foods, Inc. dba UNFI | 41163-986 |
| Nighttime Sleep Aid | Doxylamine succinate 25 mg/1 | TabletOral | Family Dollar Stores, Inc | 55319-439 |
| Unisom SleepTabsdoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Chattem, Inc. | 41167-0608 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Amerisource Bergen | 46122-788 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Meijer Distribution Inc | 41250-986 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Bi-Mart | 37835-831 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Grocery Outlet | 85828-439 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | CVS PHARMACY | 69842-386 |
| Sleep-Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Cardinal Health 110, LLC. DBA Leader | 70000-0567 |
| SLEEP AID 25mgdoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | YYBA CORP | 73581-205 |
| Nighttime Sleep-Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Kroger Company | 30142-366 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Kroger Company | 30142-386 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | COSTCO WHOLESALE CORPORATION | 63981-986 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Walgreen Company | 0363-0386 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | L.N.K. International, Inc. | 50844-260 |
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