Dicyclomine hydrochloride
- Product NDC
- 16571-259
- 11-digit product format
- 165710259
- Labeler code
- 16571
- Product ID
- 16571-259_c68c26a1-6f4c-4853-9e9d-1e2e2e3d5a6c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA218952
- Marketing category
- ANDA
- Marketing start
- 2024-11-15
- 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 |
|---|
| 16571-259-01 | Dicyclomine hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 16571-259-10 | Dicyclomine hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-259 | DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE) TABLET [RISING PHARMA HOLDINGS, INC.] | 3 | Current NDC, 2 package rows | 20250417_0a97e9c8-7046-4b92-93ad-dd9e01ce0fc4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 16571-259-01 | 16571025901 | 100 TABLET in 1 BOTTLE (16571-259-01) | 100 tablet | 2024-11-15 | No | No | Current |
| 16571-259-10 | 16571025910 | 1000 TABLET in 1 BOTTLE (16571-259-10) | 1000 tablet | 2024-11-15 | No | No | Current |