Over-the-counter drug · ANDA

Nighttime Sleep Aid (Doxylamine succinate) NDC 50844-386

Doxylamine succinate 25 mg/1 · Tablet · Oral · L.N.K. International, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)50844-386Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50844-0386Add 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
50844-386-1950844038619508440386191 BLISTER PACK in 1 CARTON (50844-386-19) / 8 TABLET in 1 BLISTER PACKMarketed from Apr 11, 2002
50844-386-2250844038622508440386223 BLISTER PACK in 1 CARTON (50844-386-22) / 16 TABLET in 1 BLISTER PACKMarketed from Apr 11, 2002
50844-386-2750844038627508440386272 BLISTER PACK in 1 CARTON (50844-386-27) / 16 TABLET in 1 BLISTER PACKMarketed from Apr 11, 2002
50844-386-90508440386905084403869032 TABLET in 1 BOTTLE, PLASTIC (50844-386-90)Marketed from Apr 11, 2002
50844-386-9650844038696508440386962 BOTTLE, PLASTIC in 1 CARTON (50844-386-96) / 96 TABLET in 1 BOTTLE, PLASTICMarketed from Apr 11, 2002

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
L.N.K. International, Inc.NDC labeler code 50844
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 50844-386_b218dc14-c46a-4fef-a17e-ffb3edd284f7SPL ID b218dc14-c46a-4fef-a17e-ffb3edd284f7SPL set ID 918ad808-ccfd-429f-9052-19905a634606RxCUI 1101446UNII V9BI9B5YI2UPC 0350844386199
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

N450844038619 followed by a unit qualifier and the quantity

Package 50844-0386-19. 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 50844-386

What is NDC 50844-386?
50844-386 is the product NDC for Nighttime Sleep Aid (doxylamine succinate), Doxylamine succinate 25 mg/1 tablet, listed with the FDA by L.N.K. International, Inc.. It has 5 package NDCs, 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?
L.N.K. International, Inc., NDC labeler code 50844. 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
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 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/1TabletOralARMY AND AIR FORCE EXCHANGE SERVICE55301-986
Sleep Aiddoxylamine succinateDoxylamine succinate 25 mg/1TabletOralCOSTCO WHOLESALE CORPORATION63981-986

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