Over-the-counter drug · ANDA

Nighttime Sleep Aid (Doxylamine succinate) NDC 59779-441

Doxylamine succinate 25 mg/1 · Tablet · Oral · CVS Pharmacy

NDC codes

FDA NDC Directory
Product NDC (as listed)59779-441Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59779-0441Add 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
59779-441-0159779044101597790441011 BOTTLE in 1 CARTON (59779-441-01) / 96 TABLET in 1 BOTTLEMarketed from May 9, 2018

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
CVS PharmacyNDC labeler code 59779
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040167
Marketing start
Listing expires
Other FDA classes
Histamine Receptor Antagonists (Mechanism)
Identifiers
Product ID 59779-441_16ca467b-a34f-4839-a0f2-feb1a2b446ceSPL ID 16ca467b-a34f-4839-a0f2-feb1a2b446ceSPL set ID 05050b61-2417-48f0-9478-c39d6a341026RxCUI 1101446UNII 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

N459779044101 followed by a unit qualifier and the quantity

Package 59779-0441-01. 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 59779-441

What is NDC 59779-441?
59779-441 is the product NDC for Nighttime Sleep Aid (doxylamine succinate), Doxylamine succinate 25 mg/1 tablet, listed with the FDA by CVS Pharmacy. 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?
CVS Pharmacy, NDC labeler code 59779. 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 040167

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

FDA NDC Directory listings under ANDA 040167
ProductStrengthForm · routeLabelerProduct NDC
Basic Care Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralAmazon.com Services LLC72288-441
berkley and jensen sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralBJWC68391-441
CareOne Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralAmerican Sales Company41520-634
dg health sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralDolgencorp Inc55910-909
Good sense sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralL. Perrigo Company0113-0441
good sense sleep aid ultradoxylamine succinateDoxylamine succinate 25 mg/1Tablet, CoatedOralL. Perrigo Company0113-4032
good sense sleep aid ultradoxylamine succinateDoxylamine succinate 25 mg/1TabletOralL. Perrigo Company0113-6044
nighttime sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralHyVee Inc42507-033
sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralWalgreen Company0363-3462
sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralRite Aid Corporation11822-0441
sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralRite Aid Corporation11822-3000
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralMeijer Distribution Inc41250-441
sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralPublix Super Markets Inc56062-441
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralAmazon.com Services LLC72288-432
sleep aid ultradoxylamine succinateDoxylamine succinate 25 mg/1TabletOralMeijer, Inc.79481-0096
TopCare Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralTopco Associates LLC36800-441
Topcare Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralTopco Associates LLC76162-159
topcare sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1Tablet, CoatedOralTopco Associates LLC76162-603
ultra sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralWalgreen Company0363-8011
Unisom SleepTabsdoxylamine succinateDoxylamine succinate 25 mg/1TabletOralChattem, Inc.41167-0063

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