Dicyclomine Hydrochloride
- Product NDC
- 68071-3648
- 11-digit product format
- 680713648
- Labeler code
- 68071
- Product ID
- 68071-3648_1e0260db-10a7-df23-e063-6394a90ac3cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA216782
- Marketing category
- ANDA
- Marketing start
- 2023-07-01
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CQ903KQA31 |
| Rxcui | 991086 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3648-6 | Dicyclomine Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3648 | DICYCLOMINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.] | 1 | Current NDC, 1 package rows | 20240725_1e0260d0-aaad-aa9f-e063-6294a90a531a.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 |
|---|
| 68071-3648-6 | 68071364806 | 100 TABLET in 1 BOTTLE, PLASTIC (68071-3648-6) | 100 tablet | 2024-07-24 | No | No | Historical |