Laxative
- Product NDC
- 76162-676
- 11-digit product format
- 761620676
- Labeler code
- 76162
- Product ID
- 76162-676_5ead2a1a-2d35-415f-b63c-cdf60b93e5d3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Bisacodyl
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- TOPCO ASSOCIATES LLC
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-04-20
- Substance
- BISACODYL
- Active strength
- 5 mg/1
- Pharmacologic classes
- Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Laxative
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BISACODYL | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 10X0709Y6I |
| Rxcui | 308753 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76162-676-01 | Laxative | 2 in 1 CARTON | TABLET, DELAYED RELEASE | 2 | | 4 |
| 76162-676-01 | Laxative | 15 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 15 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76162-676 | LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 3 | Current NDC, 2 package rows | 20250429_dcb1b698-a6ac-4820-8e51-67256634e73f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76162-676-01 | 76162067601 | 2 BLISTER PACK in 1 CARTON (76162-676-01) / 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 2 blister pack | 2024-04-20 | No | No | Historical |