Over-the-counter drug · OTC MONOGRAPH DRUG
Docusate Sodium NDC 53345-035
Docusate sodium 250 mg/1 · Capsule, Liquid filled · Oral · Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
NDC codes
FDA NDC Directory| 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
- Listing expires
- 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
N453345003501followed by a unit qualifier and the quantityPackage 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 .
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.
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.
Related NDCs: other Docusate Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under M 007
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Stool Softenerdocusate sodium | Docusate sodium 100 mg/1 | Capsule, Liquid filledOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-938 |
| Glycerin | Glycerin 1 g/1 | SuppositoryRectal | Chain Drug Consortium LLC | 68016-161 |
| Bisacodyl | Bisacodyl 10 mg/1 | SuppositoryRectal | CVS Pharmacy | 69842-816 |
| Mineral oil | Mineral oil 100 mg/100mL | OilOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-035 |
| Epsom Saltmagnesium sulfate | Magnesium sulfate, Unspecified 1 g/g | GranuleOral, Topical | Whole Foods Market | 42681-6412 |
| Stratuscare Glycerin Laxative Pediatricglycerin | Glycerin 1 g/1 | SuppositoryRectal | Stratus Pharmaceuticals | 58980-409 |
| Senokotstandardized senna concentrate | Sennosides 8.6 mg/1 | TabletOral | Atlantis Consumer Healthcare, Inc. | 67618-300 |
| Senna | Sennosides a and b 8.8 mg/5mL | SolutionOral | Rugby Laboratories | 0536-1483 |
| Milk Of Magnesia Cherrymagnesium hydroxide | Magnesium hydroxide 1200 mg/15mL | LiquidOral | TOP CARE (TOPCO ASSOCIATES LLC) | 36800-684 |
| Epsom Saltmagnesium sulfate | Magnesium sulfate, Unspecified 1 g/g | GranuleOral, Topical | Whole Foods Market | 42681-6413 |
| Stratuscare Adult Glyceringlycerin | Glycerin 2 g/1 | SuppositoryRectal | Stratus Pharmaceuticals | 58980-410 |
| Phillips Fresh Mint Milk Of Magnesia | Magnesium hydroxide 1200 mg/15mL | LiquidOral | Bayer HealthCare LLC. | 0280-0031 |
| Senokot-Sstandardized senna concentrate and docusate sodium | Sennosides 8.6 mg/1; Docusate sodium 50 mg/1 | TabletOral | Atlantis Consumer Healthcare, Inc. | 67618-310 |
| Senexon-Sdocusate sodium 50mg and sennosides 8.6mg | Sennosides 8.6 mg/1; Docusate sodium 50 mg/1 | Tablet, Film coatedOral | RUGBY LABORATORIES | 0536-1247 |
| Equate Kids Gentle Laxative SCmagnesium hydroxide | Magnesium hydroxide 1200 mg/1 | Tablet, ChewableOral | Walmart | 79903-252 |
| Stratuscare Bisacodylbisacodyl | Bisacodyl 10 mg/1 | SuppositoryRectal | Stratus Pharmaceuticals | 58980-415 |
| Epsom Saltmagnesium sulfate | Magnesium sulfate heptahydrate 1 g/g | Granule, For solutionOral, Topical | Vi-Jon, LLC | 0869-0602 |
| Fleetbisacodyl | Bisacodyl 5 mg/1 | Tablet, CoatedOral | C.B. Fleet Company, Inc. | 0132-0401 |
| Stool Softenerdocusate sodium | Docusate sodium 100 mg/1 | TabletOral | Geri-Care Pharmaceuticals, Corp | 57896-421 |
| Stool Softener Extra Strengthdocusate sodium | Docusate sodium 250 mg/1 | Capsule, Liquid filledOral | CVS Pharmacy | 69842-740 |
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