Dicyclomine Hydrochloride
- Product NDC
- 70954-261
- 11-digit product format
- 709540261
- Labeler code
- 70954
- Product ID
- 70954-261_b0911994-0b36-439d-8247-5d885a899421
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Novitium Pharma LLC
- Application
- ANDA214721
- Marketing category
- ANDA
- Marketing start
- 2021-04-23
- 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 |
|---|
| 70954-261-10 | Dicyclomine Hydrochloride | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-261 | DICYCLOMINE HYDROCHLORIDE SOLUTION [NOVITIUM PHARMA LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20210507_b0911994-0b36-439d-8247-5d885a899421.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 |
|---|
| 70954-261-10 | 70954026110 | 473 mL in 1 BOTTLE (70954-261-10) | 473 ml | 2021-04-23 | 0000-00-00 | No | No | Current |