DICYCLOMINE HYDROCHLORIDE
- Product NDC
- 72789-539
- 11-digit product format
- 727890539
- Labeler code
- 72789
- Product ID
- 72789-539_4e95e6a9-bd74-4291-e063-6294a90ae0b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DICYCLOMINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA216760
- Marketing category
- ANDA
- Marketing start
- 2025-06-10
- 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 |
|---|
| 72789-539-01 | DICYCLOMINE HYDROCHLORIDE | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 2 |
| 72789-539-95 | DICYCLOMINE HYDROCHLORIDE | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-539-01 | 72789053901 | 100 TABLET in 1 BOTTLE, PLASTIC (72789-539-01) | 100 tablet | 2026-04-03 | No | No | Historical |
| 72789-539-95 | 72789053995 | 1000 TABLET in 1 BOTTLE, PLASTIC (72789-539-95) | 1000 tablet | 2026-04-03 | No | No | Historical |