Dicyclomine Hydrochloride
- Product NDC
- 67046-1258
- 11-digit product format
- 670461258
- Labeler code
- 67046
- Product ID
- 67046-1258_508a6d6b-0713-4b01-e063-6294a90a293d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA040319
- Marketing category
- ANDA
- Marketing start
- 2026-04-28
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CQ903KQA31 |
| Rxcui | 991061 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67046-1258-3 | Dicyclomine Hydrochloride | 30 in 1 BLISTER PACK | CAPSULE | 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 |
|---|
| 67046-1258-3 | 67046125803 | 30 CAPSULE in 1 BLISTER PACK (67046-1258-3) | 30 capsule | 2026-04-28 | No | No | Historical |