Dicyclomine hydrochloride
- Product NDC
- 68071-3885
- 11-digit product format
- 680713885
- Labeler code
- 68071
- Product ID
- 68071-3885_42b52c4d-27fe-7582-e063-6394a90ab45c
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dicyclomine hydrochloride
- Listing expiration
- 2026-12-31
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 |
|---|
| 68071-3885-2 | Dicyclomine hydrochloride | 20 in 1 BOTTLE | TABLET | 20 | | 3 |
| 68071-3885-3 | Dicyclomine hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 68071-3885-6 | Dicyclomine hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3885-2 | 68071388502 | 20 TABLET in 1 BOTTLE (68071-3885-2) | 20 tablet | 2025-08-15 | No | No | Current |
| 68071-3885-3 | 68071388503 | 30 TABLET in 1 BOTTLE (68071-3885-3) | 30 tablet | 2025-08-15 | No | No | Current |
| 68071-3885-6 | 68071388506 | 60 TABLET in 1 BOTTLE (68071-3885-6) | 60 tablet | 2025-11-03 | No | No | Current |