Dicyclomine hydrochloride
- Product NDC
- 0832-6053
- 11-digit product format
- 008326053
- Labeler code
- 0832
- Product ID
- 0832-6053_4368e60e-34d6-f0c2-e063-6294a90a1dbd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- ANDA216639
- Marketing category
- ANDA
- Marketing start
- 2023-03-24
- Marketing end
- 2026-09-30
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dicyclomine hydrochloride
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 |
|---|
| 0832-6053-10 | Dicyclomine hydrochloride | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 2 |
| 0832-6053-11 | Dicyclomine hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0832-6053 | DICYCLOMINE HYDROCHLORIDE CAPSULE [UPSHER-SMITH LABORATORIES, LLC] | 1 | Current NDC, 2 package rows | 20230416_c60cb7fd-0ec7-4b6c-a535-34d79b2167b6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0832-6053-10 | 00832605310 | 1000 CAPSULE in 1 BOTTLE (0832-6053-10) | 1000 capsule | 2023-04-13 | 2026-09-30 | No | No | Historical |
| 0832-6053-11 | 00832605311 | 100 CAPSULE in 1 BOTTLE (0832-6053-11) | 100 capsule | 2023-04-13 | 2026-09-30 | No | No | Historical |