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
Product NDC (as listed)80513-371Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80513-0371Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
80513-371-2580513037125225 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
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

N480513037125 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040564

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 040564
ProductStrengthForm · routeLabelerProduct NDC
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralH E B37808-886
SLEEP AID 25mgdoxylamine succinateDoxylamine succinate 25 mg/1TabletOralYYBA CORP73581-205
Nocto Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralBelmora LLC27854-375
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralUnited Natural Foods, Inc. dba UNFI41163-986
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralAmerisource Bergen46122-788
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralCVS PHARMACY69842-386
Sleep-Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralCardinal Health 110, LLC. DBA Leader70000-0567
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralL.N.K. International, Inc.50844-260
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralWalgreen Company0363-0386
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralL.N.K. International, Inc.50844-386
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralARMY AND AIR FORCE EXCHANGE SERVICE55301-986
Unisom SleepTabsdoxylamine succinateDoxylamine succinate 25 mg/1TabletOralChattem, Inc.41167-0608
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralCOSTCO WHOLESALE CORPORATION63981-986
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralBetter Living Brands, LLC21130-986
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-368
Nighttime Sleep AidDoxylamine succinate 25 mg/1TabletOralAllegiant Health69168-439
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralStrategic Sourcing Services LLC70677-1129
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralMeijer Distribution Inc41250-986
Nighttime Sleep-Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralKroger Company30142-366
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralKroger Company30142-386

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