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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dicyclomine hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICYCLOMINE HYDROCHLORIDE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CQ903KQA31 |
| Rxcui | 991086 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8622-39 | Dicyclomine hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |