Dicyclomine hydrochloride
- Product NDC
- 72888-119
- 11-digit product format
- 728880119
- Labeler code
- 72888
- Product ID
- 72888-119_4b7e07c5-f687-74a5-e063-6294a90aa7ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advagen Pharma Ltd.,
- Application
- ANDA216736
- Marketing category
- ANDA
- Marketing start
- 2022-12-14
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dicyclomine hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICYCLOMINE HYDROCHLORIDE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CQ903KQA31 |
| Rxcui | 991086, 2719470 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72888-119-00 | Dicyclomine hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
| 72888-119-01 | Dicyclomine hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 72888-119-05 | Dicyclomine hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
| 72888-119-30 | Dicyclomine hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72888-119 | DICYCLOMINE HYDROCHLORIDE TABLET [ADVAGEN PHARMA LTD.,] | 1 | Current NDC, 4 package rows | 20230119_b4331e24-58af-45fb-a25b-9eb8270f83f7.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 |
|---|
| 72888-119-00 | 72888011900 | 1000 TABLET in 1 BOTTLE (72888-119-00) | 1000 tablet | 2022-12-14 | No | No | Current |
| 72888-119-01 | 72888011901 | 100 TABLET in 1 BOTTLE (72888-119-01) | 100 tablet | 2022-12-14 | No | No | Current |
| 72888-119-05 | 72888011905 | 500 TABLET in 1 BOTTLE (72888-119-05) | 500 tablet | 2022-12-14 | No | No | Current |
| 72888-119-30 | 72888011930 | 30 TABLET in 1 BOTTLE (72888-119-30) | 30 tablet | 2022-12-14 | No | No | Current |