Dicyclomine hydrochloride
- Product NDC
- 31722-052
- 11-digit product format
- 317220052
- Labeler code
- 31722
- Product ID
- 31722-052_1e764ead-f2ea-f00c-e063-6294a90ae86b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA218018
- Marketing category
- ANDA
- Marketing start
- 2024-07-01
- 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 |
|---|
| 31722-052-01 | Dicyclomine hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
| 31722-052-05 | Dicyclomine hydrochloride | 500 in 1 BOTTLE | CAPSULE | 500 | | 1 |
| 31722-052-10 | Dicyclomine hydrochloride | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-052 | DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE) CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, 3 package rows | 20240731_600f3b80-0303-4f2d-929b-edb689b5b357.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 |
|---|
| 31722-052-01 | 31722005201 | 100 CAPSULE in 1 BOTTLE (31722-052-01) | 100 capsule | 2024-07-01 | No | No | Historical |
| 31722-052-05 | 31722005205 | 500 CAPSULE in 1 BOTTLE (31722-052-05) | 500 capsule | 2024-07-01 | No | No | Historical |
| 31722-052-10 | 31722005210 | 1000 CAPSULE in 1 BOTTLE (31722-052-10) | 1000 capsule | 2024-07-01 | No | No | Historical |