Over-the-counter drug · ANDA

Unisom SleepTabs (doxylamine succinate) NDC 41167-0063

Doxylamine succinate 25 mg/1 · Tablet · Oral · Chattem, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)41167-0063Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41167-0063Add 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
41167-0063-5411670063051 BLISTER PACK in 1 CARTON (41167-0063-5) / 16 TABLET in 1 BLISTER PACKMarketed from Jan 15, 2016
41167-0063-6411670063061 BOTTLE, PLASTIC in 1 CARTON (41167-0063-6) / 32 TABLET in 1 BOTTLE, PLASTICMarketed from Jan 15, 2016
41167-0063-7411670063071 BOTTLE, PLASTIC in 1 CARTON (41167-0063-7) / 48 TABLET in 1 BOTTLE, PLASTICMarketed from Jan 15, 2016
41167-0063-8411670063081 BOTTLE, PLASTIC in 1 CARTON (41167-0063-8) / 80 TABLET in 1 BOTTLE, PLASTICMarketed from Jan 15, 2016

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)
Unisom SleepTabs
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 040167
Marketing start
Listing expires
Other FDA classes
Histamine Receptor Antagonists (Mechanism)
Identifiers
Product ID 41167-0063_32b4f344-3f75-4804-b8cb-800fe2b508c0SPL ID 32b4f344-3f75-4804-b8cb-800fe2b508c0SPL set ID f591d52f-5610-4517-a96f-1ed63deb00bcRxCUI 1101446, 1101448UNII 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

N441167006305 followed by a unit qualifier and the quantity

Package 41167-0063-05. 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)

Uses 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 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
sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralRite Aid Corporation11822-3000
Basic Care Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralAmazon.com Services LLC72288-441
berkley and jensen sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralBJWC68391-441
good sense sleep aid ultradoxylamine succinateDoxylamine succinate 25 mg/1Tablet, CoatedOralL. Perrigo Company0113-4032
Vicks ZzzQuil Ultradoxylamine succinateDoxylamine succinate 25 mg/1TabletOralThe Procter & Gamble Manufacturing Company69423-902
Topcare Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralTopco Associates LLC76162-159
CareOne Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralAmerican Sales Company41520-634
good sense sleep aid ultradoxylamine succinateDoxylamine succinate 25 mg/1TabletOralL. Perrigo Company0113-6044
up and up nighttime sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralTarget Corporation11673-171
Good sense sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralL. Perrigo Company0113-0441
Nighttime Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralCVS Pharmacy59779-441
sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralRite Aid Corporation11822-0441
topcare sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1Tablet, CoatedOralTopco Associates LLC76162-603
dg health sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralDolgencorp Inc55910-909
TopCare Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralTopco Associates LLC36800-441
sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralWalgreen Company0363-3462
ultra sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralWalgreen Company0363-8011
sleep aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralPublix Super Markets Inc56062-441
sleep aid ultradoxylamine succinateDoxylamine succinate 25 mg/1TabletOralMeijer, Inc.79481-0096
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralMeijer Distribution Inc41250-441

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