DICYCLOMINE HYDROCHLORIDE
- Product NDC
- 72789-546
- 11-digit product format
- 727890546
- Labeler code
- 72789
- Product ID
- 72789-546_47e64690-d756-1ea9-e063-6394a90a1499
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DICYCLOMINE HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA216639
- Marketing category
- ANDA
- Marketing start
- 2025-09-30
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CQ903KQA31 |
| Rxcui | 991061 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-546-28 | DICYCLOMINE HYDROCHLORIDE | 28 in 1 BOTTLE, PLASTIC | CAPSULE | 28 | | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-546-28 | 72789054628 | 28 CAPSULE in 1 BOTTLE, PLASTIC (72789-546-28) | 28 capsule | 2026-01-08 | No | No | Historical |