Dicyclomine Hydrochloride
- Product NDC
- 70518-4331
- 11-digit product format
- 705184331
- Labeler code
- 70518
- Product ID
- 70518-4331_40301a39-d985-9366-e063-6394a90acdd9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA040319
- Marketing category
- ANDA
- Marketing start
- 2025-04-19
- 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 |
|---|
| 70518-4331-0 | Dicyclomine Hydrochloride | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 3 |
| 70518-4331-1 | Dicyclomine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4331 | DICYCLOMINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] | 1 | Current NDC, 2 package rows | 20250423_e67ad329-6395-4fa0-a898-f13959034e26.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 |
|---|
| 70518-4331-0 | 70518433100 | 30 CAPSULE in 1 BLISTER PACK (70518-4331-0) | 30 capsule | 2025-04-19 | No | No | Current |
| 70518-4331-1 | 70518433101 | 30 CAPSULE in 1 BOTTLE, PLASTIC (70518-4331-1) | 30 capsule | 2025-08-27 | No | No | Current |