Over-the-counter drug · OTC MONOGRAPH DRUG
stimulant laxative enteric coated (Bisacodyl) NDC 71610-453
Bisacodyl 5 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-453-02 | 7161004530271610045302 | 2 TABLET in 1 BOTTLE (71610-453-02)Marketed from Aug 28, 2020 | |
| 71610-453-04 | 7161004530471610045304 | 4 TABLET in 1 BOTTLE (71610-453-04)Marketed from Jul 31, 2020 | |
| 71610-453-20 | 7161004532071610045320 | 20 TABLET in 1 BOTTLE (71610-453-20)Marketed from Sep 20, 2021 |
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 enteric coated
- Generic name (nonproprietary)
- bisacodyl
- Active ingredients
- Bisacodyl — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 71610-453_2b4c7710-ccef-da92-e063-6394a90a5416SPL ID 2b4c7710-ccef-da92-e063-6394a90a5416SPL set ID 0331c762-d318-48d6-97ed-86499c6c8b30RxCUI 308753UNII 10X0709Y6I
- 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
N471610045302followed by a unit qualifier and the quantityPackage 71610-0453-02. 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 relieves occasional constipation and irregularity generally produces a bowel movement in 6 to 12 hours
Excerpt only. Read the full label for complete information.
About NDC 71610-453
- What is NDC 71610-453?
- 71610-453 is the product NDC for stimulant laxative enteric coated, Bisacodyl 5 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- stimulant laxative enteric coated (Bisacodyl).
- What is the active ingredient?
- Bisacodyl.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 enteric coated?
- 4 other product NDCs are listed under this name. See all stimulant laxative enteric coated 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 enteric coated 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 laxative enteric coatedbisacodyl | Bisacodyl 5 mg/1 | TabletOral | Sportpharm LLC | 85766-148 | 85766-0148-0085766-0148-0185766-0148-02+2 more |
| Stimulant Laxative Enteric Coatedbisacodyl | Bisacodyl 5 mg/1 | TabletOral | SDA Laboratories, Inc. | 66424-002 | 66424-0002-01 |
| stimulant laxative enteric coatedbisacodyl | Bisacodyl 5 mg/1 | TabletOral | Geri-Care Pharmaceutical Corp | 57896-441 | 57896-0441-0157896-0441-1057896-0441-20+2 more |
| stimulant laxative enteric coatedbisacodyl | Bisacodyl 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1531 | 71335-1531-0071335-1531-0171335-1531-02+7 more |
Other NDCs under 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
Showing 20 of 40.