Dicyclomine Hydrochloride
- Product NDC
- 68788-8578
- 11-digit product format
- 687888578
- Labeler code
- 68788
- Product ID
- 68788-8578_eab30315-f199-40ea-a2f2-a70d138c2c60
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA040319
- Marketing category
- ANDA
- Marketing start
- 2024-02-01
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 10 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 | 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 |
|---|
| 68788-8578-1 | Dicyclomine Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 3 |
| 68788-8578-3 | Dicyclomine Hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
| 68788-8578-6 | Dicyclomine Hydrochloride | 60 in 1 BOTTLE | CAPSULE | 60 | | 3 |
| 68788-8578-9 | Dicyclomine Hydrochloride | 90 in 1 BOTTLE | CAPSULE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8578 | DICYCLOMINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, 4 package rows | 20250322_a5864c57-d73c-45c6-8985-7a041c84ccad.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 |
|---|
| 68788-8578-1 | 68788857801 | 100 CAPSULE in 1 BOTTLE (68788-8578-1) | 100 capsule | 2024-12-06 | No | No | Current |
| 68788-8578-3 | 68788857803 | 30 CAPSULE in 1 BOTTLE (68788-8578-3) | 30 capsule | 2024-02-01 | No | No | Current |
| 68788-8578-6 | 68788857806 | 60 CAPSULE in 1 BOTTLE (68788-8578-6) | 60 capsule | 2024-12-06 | No | No | Current |
| 68788-8578-9 | 68788857809 | 90 CAPSULE in 1 BOTTLE (68788-8578-9) | 90 capsule | 2024-12-06 | No | No | Current |