What is NDC 53345-035?

53345-035 is the product NDC for Docusate Sodium, Docusate sodium 250 mg/1 capsule, liquid filled, listed with the FDA by Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.

Humanwell PuraCap Pharmaceuticals (Wuhan) Co., 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?

31 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Docusate Sodium NDC 53345-035 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53345-035Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53345-0035Add 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 NDC	11-digit (billing)	Package	Copy
53345-035-01	5334500350153345003501	1 BAG in 1 BOX (53345-035-01) / 7000 CAPSULE, LIQUID FILLED in 1 BAGMarketed from Feb 10, 2016

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
Generic name (nonproprietary): docusate sodium
Active ingredients: Docusate sodium — 250 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: Humanwell PuraCap Pharmaceuticals (Wuhan) Co., LtdNDC labeler code 53345
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 007
Marketing start: Feb 10, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 53345-035_27680f73-0432-5efe-e063-6394a90ae8b7SPL ID 27680f73-0432-5efe-e063-6394a90ae8b7SPL set ID 33251cb7-b7b1-4f6c-9e10-4fa64cbf03a0RxCUI 1245468UNII 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

N453345003501 followed by a unit qualifier and the quantity

Package 53345-0035-01. 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 Nov 21, 2024.

Indications (excerpt from the label)

Uses for the prevention of dry, hard stools for relief of occasional constipation this product generally produces a bowel movement within 12 to 72 hours

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53345-035

What is NDC 53345-035?: 53345-035 is the product NDC for Docusate Sodium, Docusate sodium 250 mg/1 capsule, liquid filled, listed with the FDA by Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Docusate Sodium.
What is the active ingredient?: Docusate sodium.
Who is the labeler?: Humanwell PuraCap Pharmaceuticals (Wuhan) Co., 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?: 31 other product NDCs are listed under this name. See all Docusate Sodium 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 Docusate Sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Docusate Sodium	Docusate sodium 100 mg/1	Capsule, Liquid filledOral	Cardinal Health 107, LLC	55154-0578	55154-0578-00
Docusate Sodium	Docusate sodium 100 mg/1	CapsuleOral	Forreal Pharmaceuticals, LLC	81877-840	81877-0840-90
Docusate Sodium	Docusate sodium 100 mg/1	Capsule, Liquid filledOral	Major Pharmaceuticals	0904-7609	00904-7609-61
Docusate Sodium	Docusate sodium 100 mg/10mL	LiquidOral	American Health Packaging	60687-878	60687-0878-56
Docusate Sodium	Docusate sodium 100 mg/10mL	LiquidOral	Belleview Bio Science	84447-011	84447-0011-01
Docusate Sodium	Docusate sodium 100 mg/1	Capsule, Liquid filledOral	Preferred Pharmaceuticals Inc.	68788-8658	68788-8658-0368788-8658-0668788-8658-09
Docusate Sodium	Docusate sodium 50 mg/5mL	LiquidOral	Cardinal Health 107, LLC	55154-2346	55154-2346-05
Docusate sodium	Docusate sodium 100 mg/1	Capsule, Liquid filledOral	APNAR PHARMA LP	24689-130	24689-0130-01
Docusate Sodium	Docusate sodium 100 mg/10mL	LiquidOral	Major Pharmaceuticals	0904-7279	00904-7279-72
Docusate Sodium	Docusate sodium 100 mg/1	Capsule, Liquid filledOral	NuCare Pharmaceuticals,Inc.	68071-3438	68071-3438-0368071-3438-06

All 32 Docusate Sodium NDCs

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
Product	Strength	Form · route	Labeler	Product NDC
365 Whole Foods Market Epsom Saltmagnesium sulfate	Magnesium sulfate heptahydrate 1 g/g	Granule, For solutionOral, Topical	Whole Foods Market, Inc.	42681-0060
4718 Enema, Mineral Oil	Mineral oil 133 g/133mL	EnemaRectal	Dynarex	67777-430
Acetaminophenextra strength pain relief	Acetaminophen 500 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-5239
Alcohol wet wipes	Alcohol 75 mL/100mL	DressingTopical	Shandong Aishule Hygiene Products Co., Ltd	82061-006
Amazon Fiber Capletscalcium polycarbophil	Calcium polycarbophil 625 mg/1	Tablet, Film coatedOral	AMAZON.COM SERVICES LLC	72288-201
Amazon Fiber Therapymethylcellulose	Methylcellulose (4000 mpa.s) 500 mg/1	TabletOral	AMAZON.COM SERVICES LLC	72288-122
Anecream 5lidocaine 5%	Lidocaine 5 g/100g	CreamTopical	Focus Health Group	24357-702
basic care stool softenerdocusate sodium	Docusate sodium 100 mg/1	Capsule, Liquid filledOral	Amazon.com Services LLC	72288-486
Best Choicecalcium polycarbophil	Calcium polycarbophil 625 mg/1	Tablet, Film coatedOral	BEST CHOICE (VALU MERCHANDISERS COMPANY)	63941-023
Best Choice Fiber Laxativepsyllium husk	Psyllium husk .52 g/1	CapsuleOral	BEST CHOICE (VALU MERCHANDISERS COMPANY)	63941-119
Best Choice Fiber Therapymethylcellulose	Methylcellulose (4000 mpa.s) 500 mg/1	TabletOral	BEST CHOICE (VALU MERCHANDISERS COMPANY)	63941-122
Best Choice Fiber Therapy Orange Flavorpsyllium husk	Psyllium husk 3.4 g/12g	PowderOral	BEST CHOICE (VALU MERCHANDISERS COMPANY)	63941-513
Best Choice Fiber Therapy original coarsepsyllium husk	Psyllium husk 3.4 g/7g	PowderOral	BEST CHOICE (VALU MERCHANDISERS COMPANY)	63941-511
Bisacodyl	Bisacodyl 10 mg/1	SuppositoryRectal	Padagis US LLC	0574-7050
Bisacodyl	Bisacodyl 10 mg/1	SuppositoryRectal	Major Pharmaceuticals	0904-7142
Bisacodylbiscodyl	Bisacodyl 5 mg/1	Tablet, CoatedOral	TARGET CORPORATION	11673-182
Bisacodyl	Bisacodyl 5 mg/1	Tablet, CoatedOral	KROGER COMPANY	41226-003
Bisacodyl	Bisacodyl 10 mg/1	SuppositoryRectal	Rising Pharma Holdings, Inc.	57237-327
Bisacodyl	Bisacodyl 10 mg/1	SuppositoryRectal	Pharmacy Value Alliance LLC	68016-084
Bisacodyl	Bisacodyl 10 mg/1	SuppositoryRectal	CVS Pharmacy	69842-816

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