DICYCLOMINE HYDROCHLORIDE
- Product NDC
- 16571-260
- 11-digit product format
- 165710260
- Labeler code
- 16571
- Product ID
- 16571-260_239ecf22-4237-4f27-b17c-6fddabcc9d9d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DICYCLOMINE HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA219242
- Marketing category
- ANDA
- Marketing start
- 2025-06-23
- 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 |
|---|
| 16571-260-01 | DICYCLOMINE HYDROCHLORIDE | 100 in 1 BOTTLE | CAPSULE | 100 | | 4 |
| 16571-260-10 | DICYCLOMINE HYDROCHLORIDE | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 16571-260-01 | 16571026001 | 100 CAPSULE in 1 BOTTLE (16571-260-01) | 100 capsule | 2025-06-23 | No | No | Current |
| 16571-260-10 | 16571026010 | 1000 CAPSULE in 1 BOTTLE (16571-260-10) | 1000 capsule | 2025-06-23 | No | No | Current |