NDC codes

FDA NDC Directory
Product NDC (as listed)53345-015Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53345-0015Add 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
53345-015-0153345001501533450015011 BAG in 1 BOX (53345-015-01) / 20000 CAPSULE, LIQUID FILLED in 1 BAGMarketed from Nov 12, 2013

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)
Docusate Sodium 50 Mg
Generic name (nonproprietary)
docusate sodium
Active ingredients
Docusate sodium — 50 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 007
Marketing start
Listing expires
Identifiers
Product ID 53345-015_27c70a38-225f-2753-e063-6394a90a9560SPL ID 27c70a38-225f-2753-e063-6394a90a9560SPL set ID af7533e6-8b06-48a4-940e-7ecb57b24b59RxCUI 1247759UNII F05Q2T2JA0

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

N453345001501 followed by a unit qualifier and the quantity

Package 53345-0015-01. 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)

Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53345-015

What is NDC 53345-015?
53345-015 is the product NDC for Docusate Sodium 50 Mg (docusate sodium), Docusate sodium 50 mg/1 capsule, liquid filled, listed with the FDA by Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Docusate Sodium 50 Mg (Docusate sodium).
What is the active ingredient?
Docusate sodium.
Who is the labeler?
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd., NDC labeler code 53345. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Docusate Sodium 50 Mg?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under M 007

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

FDA NDC Directory listings under M 007
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4718 Enema, Mineral OilMineral oil 133 g/133mLEnemaRectalDynarex67777-430
Acetaminophenextra strength pain reliefAcetaminophen 500 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-5239
Alcohol wet wipesAlcohol 75 mL/100mLDressingTopicalShandong Aishule Hygiene Products Co., Ltd82061-006
Amazon Fiber Capletscalcium polycarbophilCalcium polycarbophil 625 mg/1Tablet, Film coatedOralAMAZON.COM SERVICES LLC72288-201
Amazon Fiber TherapymethylcelluloseMethylcellulose (4000 mpa.s) 500 mg/1TabletOralAMAZON.COM SERVICES LLC72288-122
Anecream 5lidocaine 5%Lidocaine 5 g/100gCreamTopicalFocus Health Group24357-702
basic care stool softenerdocusate sodiumDocusate sodium 100 mg/1Capsule, Liquid filledOralAmazon.com Services LLC72288-486
Best Choicecalcium polycarbophilCalcium polycarbophil 625 mg/1Tablet, Film coatedOralBEST CHOICE (VALU MERCHANDISERS COMPANY)63941-023
Best Choice Fiber Laxativepsyllium huskPsyllium husk .52 g/1CapsuleOralBEST CHOICE (VALU MERCHANDISERS COMPANY)63941-119
Best Choice Fiber TherapymethylcelluloseMethylcellulose (4000 mpa.s) 500 mg/1TabletOralBEST CHOICE (VALU MERCHANDISERS COMPANY)63941-122
Best Choice Fiber Therapy Orange Flavorpsyllium huskPsyllium husk 3.4 g/12gPowderOralBEST CHOICE (VALU MERCHANDISERS COMPANY)63941-513
Best Choice Fiber Therapy original coarsepsyllium huskPsyllium husk 3.4 g/7gPowderOralBEST CHOICE (VALU MERCHANDISERS COMPANY)63941-511
BisacodylBisacodyl 10 mg/1SuppositoryRectalPadagis US LLC0574-7050
BisacodylBisacodyl 10 mg/1SuppositoryRectalMajor Pharmaceuticals0904-7142
BisacodylbiscodylBisacodyl 5 mg/1Tablet, CoatedOralTARGET CORPORATION11673-182
BisacodylBisacodyl 5 mg/1Tablet, CoatedOralKROGER COMPANY41226-003
BisacodylBisacodyl 10 mg/1SuppositoryRectalRising Pharma Holdings, Inc.57237-327
BisacodylBisacodyl 10 mg/1SuppositoryRectalPharmacy Value Alliance LLC68016-084
BisacodylBisacodyl 10 mg/1SuppositoryRectalCVS Pharmacy69842-816

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