Dicyclomine Hydrochloride
- Product NDC
- 43063-629
- 11-digit product format
- 430630629
- Labeler code
- 43063
- Product ID
- 43063-629_2cefb3a8-53f9-e570-e063-6394a90a0aba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA085082
- Marketing category
- ANDA
- Marketing start
- 1986-06-19
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 10 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 |
|---|
| 43063-629-28 | 43063062928 | 28 CAPSULE in 1 BOTTLE, PLASTIC (43063-629-28) | 28 capsule | 2015-10-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Dicyclomine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | 2025-01-30 | HUMAN PRESCRIPTION DRUG LABEL | 26 |