DICYCLOMINE HYDROCHLORIDE
- Product NDC
- 70069-431
- 11-digit product format
- 700690431
- Labeler code
- 70069
- Product ID
- 70069-431_a927b130-5b1b-462f-bb0c-2ea8763487ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DICYCLOMINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA214332
- Marketing category
- ANDA
- Marketing start
- 2024-11-05
- 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 |
|---|
| 70069-431-01 | DICYCLOMINE HYDROCHLORIDE | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 5 |
| 70069-431-05 | DICYCLOMINE HYDROCHLORIDE | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-431 | DICYCLOMINE HYDROCHLORIDE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC] | 5 | Current NDC, 2 package rows | 20241106_7ad77f59-e24a-406d-95bf-3d5c6cbc3cbe.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 |
|---|
| 70069-431-01 | 70069043101 | 2 mL in 1 VIAL | 2 ml | | | | Historical |
| 70069-431-05 | 70069043105 | 5 VIAL in 1 CARTON (70069-431-05) / 2 mL in 1 VIAL (70069-431-01) | 5 vial | 2024-11-05 | No | No | Current |