Dicyclomine hydrochloride
- Product NDC
- 0615-8622
- 11-digit product format
- 006158622
- Labeler code
- 0615
- Product ID
- 0615-8622_3d59ff86-ea36-40b2-8f75-1cdfb41cd3e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA216736
- Marketing category
- ANDA
- Marketing start
- 2022-12-14
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 |
|---|
| 0615-8622-39 | 00615862239 | 30 TABLET in 1 BLISTER PACK (0615-8622-39) | 30 tablet | 2026-02-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Dicyclomine hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | 2026-02-26 | HUMAN PRESCRIPTION DRUG LABEL | 1 |