DICYCLOMINE HYDROCHLORIDE
- Product NDC
- 51662-1559
- 11-digit product format
- 516621559
- Labeler code
- 51662
- Product ID
- 51662-1559_0f8de121-b5e5-3048-e063-6294a90afd7c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DICYCLOMINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA210257
- Marketing category
- ANDA
- Marketing start
- 2021-07-19
- 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 |
|---|
| 51662-1559-2 | DICYCLOMINE HYDROCHLORIDE | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 2 |
| 51662-1559-2 | DICYCLOMINE HYDROCHLORIDE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 2 |
| 51662-1559-3 | DICYCLOMINE HYDROCHLORIDE | 5 in 1 CASE | INJECTION, SOLUTION | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1559 | DICYCLOMINE HYDROCHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 2 | Current NDC, Legacy NDC, 3 package rows | 20240123_c77ef2f7-a846-5e05-e053-2995a90aaae0.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 |
|---|
| 51662-1559-2 | 51662155902 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | | | | | Historical |
| 51662-1559-3 | 51662155903 | 5 POUCH in 1 CASE (51662-1559-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1559-2) / 2 mL in 1 VIAL, SINGLE-DOSE | 5 pouch | 2021-07-19 | 0000-00-00 | No | No | Current |