Dicyclomine hydrochloride
- Product NDC
- 0615-8483
- 11-digit product format
- 006158483
- Labeler code
- 0615
- Product ID
- 0615-8483_d6f45cf6-4b7c-4248-9cea-614df0a3dc96
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA040204
- Marketing category
- ANDA
- Marketing start
- 1997-02-28
- 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 |
|---|
| 0615-8483-39 | Dicyclomine hydrochloride | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8483 | DICYCLOMINE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 2 | Current NDC, 1 package rows | 20240824_a16e7b6b-dbc9-463d-9bde-dba4f25589cf.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 |
|---|
| 0615-8483-39 | 00615848339 | 30 CAPSULE in 1 BLISTER PACK (0615-8483-39) | 30 capsule | 2023-08-15 | No | No | Current |