Over-the-counter drug · OTC MONOGRAPH NOT FINAL
Stimulant Laxative (Bisacodyl) NDC 49483-003
Bisacodyl 5 mg/1 · Tablet, Delayed release · Oral · TIME CAP LABORATORIES, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-003-00 | 4948300030049483000300 | 100000 TABLET, DELAYED RELEASE in 1 CARTON (49483-003-00)Marketed from Dec 7, 2018 | |
| 49483-003-01 | 4948300030149483000301 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-003-01)Marketed from Dec 7, 2018 | |
| 49483-003-10 | 4948300031049483000310 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-003-10)Marketed from Dec 7, 2018 | |
| 49483-003-52 | 4948300035249483000352 | 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK (49483-003-52)Marketed from Dec 7, 2018 |
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)
- Stimulant Laxative
- Generic name (nonproprietary)
- bisacodyl
- Active ingredients
- Bisacodyl — 5 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES, INC.NDC labeler code 49483
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (not final)Application part334
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 49483-003_938bf8c5-6834-6362-e053-2995a90aa7e6SPL ID 938bf8c5-6834-6362-e053-2995a90aa7e6SPL set ID e0a9f8d9-660b-431c-8043-6d8ec81f98e5RxCUI 308753UNII 10X0709Y6IUPC 0349483003529
- 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 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
N449483000300followed by a unit qualifier and the quantityPackage 49483-0003-00. 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 and irregularity this product generally produces a bowel movement in 6 to 12 hours
Excerpt only. Read the full label for complete information.
About NDC 49483-003
- What is NDC 49483-003?
- 49483-003 is the product NDC for Stimulant Laxative (bisacodyl), Bisacodyl 5 mg/1 tablet, delayed release, listed with the FDA by TIME CAP LABORATORIES, INC.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Stimulant Laxative (Bisacodyl).
- What is the active ingredient?
- Bisacodyl.
- Who is the labeler?
- TIME CAP LABORATORIES, INC., NDC labeler code 49483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Stimulant Laxative?
- 2 other product NDCs are listed under this name. See all Stimulant Laxative NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Stimulant Laxative products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Stimulant Laxativesennosides | Sennosides 15 mg/1 | Tablet, Sugar coatedOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-734 | 51316-0734-01 |
| stimulant laxativebisacodyl | Bisacodyl 5 mg/1 | Tablet, Delayed releaseOral | BIONPHARMA INC. | 69452-541 | 69452-0541-83 |
Other NDCs under part334
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 |
|---|---|---|---|---|
| Docusate Sodium | Docusate sodium 100 mg/1 | Capsule, Liquid filledOral | Preferred Pharmaceuticals Inc. | 68788-8658 |
| Freds Saline Twin Pack Laxativesodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form | Sodium phosphate, Dibasic, Unspecified form 7 g/133mL; Sodium phosphate, Monobasic, Unspecified form 19 g/133mL | EnemaRectal | FRED'S | 55315-301 |
| Marcs Twin Packsodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form | Sodium phosphate, Dibasic, Unspecified form 19 g/133mL; Sodium phosphate, Monobasic, Unspecified form 7 g/133mL | EnemaRectal | Marc Glassman Inc. | 68998-233 |
| Pro-Enema Single Saline Laxativesodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form | Sodium phosphate, Dibasic 7 g/118mL; Sodium phosphate, Monobasic, Unspecified form 19 g/118mL | EnemaRectal | Propharma Medical Supplies | 71451-001 |
| Quality Choice Single Saline Laxativesodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form | Sodium phosphate, Dibasic, Unspecified form 7 g/118mL; Sodium phosphate, Monobasic, Unspecified form 19 g/118mL | EnemaRectal | Alcyon Health, LLC. | 71443-001 |
| Saline Laxative Cherry Laxativesodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form | Sodium phosphate, Dibasic 2.7 g/45mL; Sodium phosphate, Monobasic, Unspecified form 7.2 g/45mL | LiquidOral | Dolgencorp Inc. | 55910-339 |
| Stimulant Laxative Plus Stool Softenerdocusate sodium 50 mg and sennosides 8.6 mg | Sennosides 8.6 mg/1; Docusate sodium 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-7674 |
| Stool Softening Senna Laxativesennosides 8.6 mg - docusate sodium 50 mg | Docusate sodium 50 mg/1; Sennosides a and b 8.6 mg/1 | TabletOral | TARGET CORPORATION | 11673-192 |
| Womens Gentle Laxativebisacodyl | Bisacodyl 5 mg/1 | TabletOral | TARGET CORPORATION | 11673-151 |