Over-the-counter drug · ANDA
Nocto Sleep Aid (Doxylamine succinate) NDC 27854-375
Doxylamine succinate 25 mg/1 · Tablet · Oral · Belmora LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27854-375-01 | 2785403750127854037501 | 1 BOTTLE, PLASTIC in 1 CARTON (27854-375-01) / 24 TABLET in 1 BOTTLE, PLASTICMarketed from Oct 31, 2019 |
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)
- Nocto Sleep Aid
- Generic name (nonproprietary)
- doxylamine succinate
- Active ingredients
- Doxylamine succinate — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Belmora LLCNDC labeler code 27854
- 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 27854-375_d1cd6ee0-e711-4563-99d5-7c582143263bSPL ID d1cd6ee0-e711-4563-99d5-7c582143263bSPL set ID d255309b-0023-48fe-890f-6a4fe04dbb85RxCUI 1101446, 2257285UNII V9BI9B5YI2
- 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
N427854037501followed by a unit qualifier and the quantityPackage 27854-0375-01. 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)
Use helps to reduce difficulty in falling asleep
Excerpt only. Read the full label for complete information.
About NDC 27854-375
- What is NDC 27854-375?
- 27854-375 is the product NDC for Nocto Sleep Aid (doxylamine succinate), Doxylamine succinate 25 mg/1 tablet, listed with the FDA by Belmora LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nocto Sleep Aid (Doxylamine succinate).
- What is the active ingredient?
- Doxylamine succinate.
- 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 Nocto Sleep Aid?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
|---|---|---|---|---|
| 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 |
| Night Time Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Advanced Rx LLC | 80513-371 |
| 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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