Dicyclomine Hydrochloride
- Product NDC
- 43063-112
- 11-digit product format
- 430630112
- Labeler code
- 43063
- Product ID
- 43063-112_2b251781-1d01-12a3-e063-6394a90a1963
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA085082
- Marketing category
- ANDA
- Marketing start
- 1986-06-19
- 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 |
|---|
| 43063-112-04 | Dicyclomine Hydrochloride | 4 in 1 BOTTLE, PLASTIC | CAPSULE | 4 | | 24 |
| 43063-112-06 | Dicyclomine Hydrochloride | 6 in 1 BOTTLE, PLASTIC | CAPSULE | 6 | | 24 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-112 | DICYCLOMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 24 | Current NDC, Legacy NDC, 2 package rows | 20250109_8c29140b-e181-4807-870f-28e315c6d4c4.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 |
|---|
| 43063-112-04 | 43063011204 | 4 CAPSULE in 1 BOTTLE, PLASTIC (43063-112-04) | 4 capsule | 2011-03-07 | 0000-00-00 | No | No | Current |
| 43063-112-06 | 43063011206 | 6 CAPSULE in 1 BOTTLE, PLASTIC (43063-112-06) | 6 capsule | 2011-03-07 | 0000-00-00 | No | No | Current |