Over-the-counter drug · ANDA

Sleep-Aid (Doxylamine succinate) NDC 70000-0567

Doxylamine succinate 25 mg/1 · Tablet · Oral · Cardinal Health 110, LLC. DBA Leader

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0567Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0567Add 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
70000-0567-170000056701700000567013 BLISTER PACK in 1 CARTON (70000-0567-1) / 16 TABLET in 1 BLISTER PACKMarketed from Jul 23, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Cardinal Health 110, LLC. DBA LeaderNDC labeler code 70000
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 70000-0567_b9f1f985-97d7-4029-b754-54f0d3a729ddSPL ID b9f1f985-97d7-4029-b754-54f0d3a729ddSPL set ID 96e8d6df-e717-4ffc-9502-498024c9665fRxCUI 1101446UNII V9BI9B5YI2UPC 0096295139891
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

N470000056701 followed by a unit qualifier and the quantity

Package 70000-0567-01. 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.

Full label on DailyMed (opens in a new tab)

About NDC 70000-0567

What is NDC 70000-0567?
70000-0567 is the product NDC for Sleep-Aid (doxylamine succinate), Doxylamine succinate 25 mg/1 tablet, listed with the FDA by Cardinal Health 110, LLC. DBA Leader. 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?
Cardinal Health 110, LLC. DBA Leader, NDC labeler code 70000. 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
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
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralAmerisource Bergen46122-788
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 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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