Dicyclomine hydrochloride
- Product NDC
- 68071-3916
- 11-digit product format
- 680713916
- Labeler code
- 68071
- Product ID
- 68071-3916_43e30b73-4779-d722-e063-6394a90a51de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA217566
- Marketing category
- ANDA
- Marketing start
- 2024-05-07
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| CQ903KQA31 | DICYCLOMINE HYDROCHLORIDE | 67-92-5 | DICYCLOMINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3916-6 | 68071391606 | 6 TABLET in 1 BOTTLE (68071-3916-6) | 6 tablet | 2025-11-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Dicyclomine hydrochloride | NuCare Pharmaceuticals, Inc. | 2025-11-18 | HUMAN PRESCRIPTION DRUG LABEL | 1 |