Over-the-counter drug · OTC MONOGRAPH DRUG
OneLAX (Bisacodyl) NDC 71399-8460
Bisacodyl 10 mg/1 · Suppository · Rectal · AKRON PHARMA INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71399-8460-2 | 7139984600271399846002 | 12 BLISTER PACK in 1 BOX (71399-8460-2) / 1 SUPPOSITORY in 1 BLISTER PACKMarketed from Sep 13, 2024 | |
| 71399-8460-5 | 7139984600571399846005 | 50 BLISTER PACK in 1 BOX (71399-8460-5) / 1 SUPPOSITORY in 1 BLISTER PACKMarketed from Sep 13, 2024 |
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)
- OneLAX
- Generic name (nonproprietary)
- bisacodyl
- Active ingredients
- Bisacodyl — 10 mg/1
- Dosage form
- Suppository
- Route
- Rectal
- Labeler
- AKRON PHARMA INCNDC labeler code 71399
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 007
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 71399-8460_42b7c75d-d66d-77f9-e063-6294a90a4e40SPL ID 42b7c75d-d66d-77f9-e063-6294a90a4e40SPL set ID be4eeb4d-df29-45dc-94ff-933e52c8b6f6RxCUI 198509UNII 10X0709Y6IUPC 0371399846020
- Pharmacologic class
- Stimulant Laxative
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N471399846002followed by a unit qualifier and the quantityPackage 71399-8460-02. 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 relief of occasional constipation this product usually produces bowel movement in 1/4 to 1 hour
Excerpt only. Read the full label for complete information.
About NDC 71399-8460
- What is NDC 71399-8460?
- 71399-8460 is the product NDC for OneLAX (bisacodyl), Bisacodyl 10 mg/1 suppository, listed with the FDA by AKRON PHARMA INC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- OneLAX (Bisacodyl).
- What is the active ingredient?
- Bisacodyl.
- Who is the labeler?
- AKRON PHARMA INC, NDC labeler code 71399. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for OneLAX?
- 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.
| 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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