Dicyclomine Hydrochloride
- Product NDC
- 68788-7811
- 11-digit product format
- 687887811
- Labeler code
- 68788
- Product ID
- 68788-7811_5a95bda3-347a-4367-96bb-1be4d5de3056
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA040230
- Marketing category
- ANDA
- Marketing start
- 2020-11-03
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-7811-2 | Dicyclomine Hydrochloride | 20 in 1 BOTTLE | TABLET | 20 | | 7 |
| 68788-7811-3 | Dicyclomine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
| 68788-7811-6 | Dicyclomine Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 7 |
| 68788-7811-9 | Dicyclomine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7811 | DICYCLOMINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20250322_6fb9d156-f321-4f7d-b308-2a0e6056fd71.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 |
|---|
| 68788-7811-2 | 68788781102 | 20 TABLET in 1 BOTTLE (68788-7811-2) | 20 tablet | 2020-11-03 | 0000-00-00 | No | No | Current |
| 68788-7811-3 | 68788781103 | 30 TABLET in 1 BOTTLE (68788-7811-3) | 30 tablet | 2020-11-03 | 0000-00-00 | No | No | Current |
| 68788-7811-6 | 68788781106 | 60 TABLET in 1 BOTTLE (68788-7811-6) | 60 tablet | 2020-11-03 | 0000-00-00 | No | No | Current |
| 68788-7811-9 | 68788781109 | 90 TABLET in 1 BOTTLE (68788-7811-9) | 90 tablet | 2020-11-03 | 0000-00-00 | No | No | Current |