Dicyclomine hydrochloride
- Product NDC
- 0615-8483
- 11-digit product format
- 006158483
- Labeler code
- 0615
- Product ID
- 0615-8483_d6f45cf6-4b7c-4248-9cea-614df0a3dc96
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA040204
- Marketing category
- ANDA
- Marketing start
- 1997-02-28
- 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 |
|---|
| 0615-8483-39 | 00615848339 | 30 CAPSULE in 1 BLISTER PACK (0615-8483-39) | 30 capsule | 2023-08-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Dicyclomine hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | 2024-08-23 | HUMAN PRESCRIPTION DRUG LABEL | 2 |