Dicyclomine Hydrochloride
- Product NDC
- 0054-0622
- 11-digit product format
- 000540622
- Labeler code
- 0054
- Product ID
- 0054-0622_8ad8c412-22d6-424f-9a52-48074ab28d4f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA212286
- Marketing category
- ANDA
- Marketing start
- 2020-05-22
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 10 mg/5mL
- 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/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CQ903KQA31 |
| Rxcui | 991082 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0622-63 | Dicyclomine Hydrochloride | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0622 | DICYCLOMINE HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20230513_aa5bd79d-7f18-4032-8862-0c5429b2ecaf.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 |
|---|
| 0054-0622-63 | 00054062263 | 473 mL in 1 BOTTLE (0054-0622-63) | 473 ml | 2020-05-22 | 0000-00-00 | No | No | Current |