Over-the-counter drug · ANDA

Sleep Aid (Doxylamine succinate) NDC 55301-986

Doxylamine succinate 25 mg/1 · Tablet · Oral · ARMY AND AIR FORCE EXCHANGE SERVICE

NDC codes

FDA NDC Directory
Product NDC (as listed)55301-986Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55301-0986Add 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
55301-986-2755301098627553010986272 BLISTER PACK in 1 CARTON (55301-986-27) / 16 TABLET in 1 BLISTER PACKMarketed from Apr 1, 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)
Sleep Aid
Generic name (nonproprietary)
doxylamine succinate
Active ingredients
Doxylamine succinate — 25 mg/1
Dosage form
Tablet
Route
Oral
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICENDC labeler code 55301
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 55301-986_f814504b-d6f4-4ced-b700-806ed966f68bSPL ID f814504b-d6f4-4ced-b700-806ed966f68bSPL set ID 009df4c9-a524-4b8f-be7a-52c521e68ff1RxCUI 1101446UNII V9BI9B5YI2UPC 0614299799868
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

N455301098627 followed by a unit qualifier and the quantity

Package 55301-0986-27. 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 55301-986

What is NDC 55301-986?
55301-986 is the product NDC for Sleep Aid (doxylamine succinate), Doxylamine succinate 25 mg/1 tablet, listed with the FDA by ARMY AND AIR FORCE EXCHANGE SERVICE. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sleep Aid (Doxylamine Succinate).
What is the active ingredient?
Doxylamine succinate.
Who is the labeler?
ARMY AND AIR FORCE EXCHANGE SERVICE, NDC labeler code 55301. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sleep Aid?
58 other product NDCs are listed under this name. See all 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 Sleep Aid NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralAmazon.com Services LLC72288-43272288-0432-01
Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralShield Pharmaceuticals Corp83059-007583059-0075-08
Sleep Aidaconitum napellus, aesculus hippocastanum, flos, arsenicum album, avena sativa, belladonna, camphora, cinchona officinalis, coffea cruda, cypripedium pubescens, hyoscyamus niger, ignatia amara, kali phosphoricum, passiflora incarnata, phosphorus, pulsatilla, and valeriana officinalis.Aconitum napellus whole 10 [hp_X]/59mL + 15 more ingredientsLiquidOralKing Bio Inc.57955-998657955-9986-02
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Chewable gelOralWalgreens0363-923600363-9236-50
Sleep-Aiddiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Chewable gelOralWALMART INC. (see also Equate)79903-42679903-0426-24
Sleep Aiddiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1CapsuleOralTARGET Corporation82442-53082442-0530-3282442-0530-60
Sleep Aiddiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1CapsuleOralWALGREENS0363-613000363-6130-2400363-6130-48
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-36851316-0368-22
sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralPublix Super Markets Inc56062-44156062-0441-01
sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralWalgreen Company0363-346200363-3462-80

All 59 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
Night Time Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralAdvanced Rx LLC80513-371
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralBetter Living Brands, LLC21130-986
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralH E B37808-886
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralBi-Mart37835-831
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralAmerisource Bergen46122-788
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralL.N.K. International, Inc.50844-260
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralL.N.K. International, Inc.50844-386
Nighttime Sleep AidDoxylamine succinate 25 mg/1TabletOralFamily Dollar Stores, Inc55319-439
Nighttime Sleep AidDoxylamine succinate 25 mg/1TabletOralAllegiant Health69168-439
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralCVS PHARMACY69842-386
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralGrocery Outlet85828-439
Nighttime Sleep-Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralKroger Company30142-366
Nocto Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralBelmora LLC27854-375
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralWalgreen Company0363-0386
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralKroger Company30142-386
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralUnited Natural Foods, Inc. dba UNFI41163-986
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralMeijer Distribution Inc41250-986
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralWal-Mart Stores Inc49035-968
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-368
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralCOSTCO WHOLESALE CORPORATION63981-986

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