Over-the-counter drug · ANDA

Nighttime Sleep Aid (Doxylamine succinate) NDC 46122-788

Doxylamine succinate 25 mg/1 · Tablet · Oral · Amerisource Bergen

NDC codes

FDA NDC Directory
Product NDC (as listed)46122-788Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46122-0788Add 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
46122-788-1546122078815461220788152 BLISTER PACK in 1 CARTON (46122-788-15) / 16 TABLET in 1 BLISTER PACKMarketed from Jun 7, 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)
Nighttime Sleep Aid
Generic name (nonproprietary)
doxylamine succinate
Active ingredients
Doxylamine succinate — 25 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Amerisource BergenNDC labeler code 46122
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 46122-788_bb1ede1d-899d-4976-b18e-7b2dba53e2daSPL ID bb1ede1d-899d-4976-b18e-7b2dba53e2daSPL set ID ea842bc4-9788-49a9-a7e1-d6e3dd61056aRxCUI 1101446UNII V9BI9B5YI2UPC 0346122788151
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

N446122078815 followed by a unit qualifier and the quantity

Package 46122-0788-15. 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)

About NDC 46122-788

What is NDC 46122-788?
46122-788 is the product NDC for Nighttime Sleep Aid (doxylamine succinate), Doxylamine succinate 25 mg/1 tablet, listed with the FDA by Amerisource Bergen. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nighttime Sleep Aid (Doxylamine Succinate).
What is the active ingredient?
Doxylamine succinate.
Who is the labeler?
Amerisource Bergen, NDC labeler code 46122. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nighttime Sleep Aid?
74 other product NDCs are listed under this name. See all Nighttime Sleep Aid NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Nighttime Sleep Aid NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralKroger41226-79341226-0793-02
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralShield Pharmaceuticals Corp83059-007383059-0073-08
nighttime sleep aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLSolutionOralAmazon.com Services LLC72288-76572288-0765-40
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralGrocery Outlet85828-43985828-0439-38
Nighttime Sleep Aiddiphenhydramine hcl 50mgDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralGrocery Outlet85828-41085828-0410-38
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralGrocery Outlet, Inc.85828-79385828-0793-01
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/1Capsule, Liquid filledOralShield Pharmaceuticals Corp83059-0122—
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralBJWC (Berkley & Jensen / BJ's)68391-61368391-0613-92
Nighttime Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 50 mg/30mLLiquidOralBJWC (Berkley & Jensen / BJ's)68391-79368391-0793-09
Nighttime Sleep AidDiphenhydramine hydrochloride 50 mg/30mLLiquidOralAllegiant Health69168-48669168-0486-39

All 75 Nighttime Sleep Aid NDCs

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
Nocto Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralBelmora LLC27854-375
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralBetter Living Brands, LLC21130-986
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralStrategic Sourcing Services LLC70677-1129
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralWal-Mart Stores Inc49035-968
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralH E B37808-886
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralUnited Natural Foods, Inc. dba UNFI41163-986
Nighttime Sleep AidDoxylamine succinate 25 mg/1TabletOralFamily Dollar Stores, Inc55319-439
Unisom SleepTabsdoxylamine succinateDoxylamine succinate 25 mg/1TabletOralChattem, Inc.41167-0608
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralMeijer Distribution Inc41250-986
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralBi-Mart37835-831
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralGrocery Outlet85828-439
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralCVS PHARMACY69842-386
Sleep-Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralCardinal Health 110, LLC. DBA Leader70000-0567
SLEEP AID 25mgdoxylamine succinateDoxylamine succinate 25 mg/1TabletOralYYBA CORP73581-205
Nighttime Sleep-Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralKroger Company30142-366
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralKroger Company30142-386
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralCOSTCO WHOLESALE CORPORATION63981-986
Night Time Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralAdvanced Rx LLC80513-371
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralWalgreen Company0363-0386
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralL.N.K. International, Inc.50844-260

Showing 20 of 24.

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