Dicyclomine Hydrochloride
- Product NDC
- 0641-6173
- 11-digit product format
- 006416173
- Labeler code
- 0641
- Product ID
- 0641-6173_856c880c-b430-43a3-a225-1fb783b6c0ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA040465
- Marketing category
- ANDA
- Marketing start
- 2015-12-30
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- 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/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CQ903KQA31 |
| Rxcui | 991065 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6173-01 | Dicyclomine Hydrochloride | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 2 | | 6 |
| 0641-6173-10 | Dicyclomine Hydrochloride | 10 in 1 CARTON | INJECTION | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6173 | DICYCLOMINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240410_26a94263-46c0-4938-849c-ffb396e48dd3.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 |
|---|
| 0641-6173-01 | 00641617301 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | | | | | Historical |
| 0641-6173-10 | 00641617310 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6173-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0641-6173-01) | | 2015-12-30 | 0000-00-00 | No | No | Current |