Dicyclomine Hydrochloride
- Product NDC
- 71335-2316
- 11-digit product format
- 713352316
- Labeler code
- 71335
- Product ID
- 71335-2316_0cdb0e0b-0f75-403d-a2b7-0386db8ffee5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA040319
- Marketing category
- ANDA
- Marketing start
- 2023-05-08
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- 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/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CQ903KQA31 |
| Rxcui | 991061 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2316-1 | 71335231601 | 30 CAPSULE in 1 BOTTLE (71335-2316-1) | 30 capsule | 2024-01-02 | No | No | Historical |
| 71335-2316-2 | 71335231602 | 90 CAPSULE in 1 BOTTLE (71335-2316-2) | 90 capsule | 2024-01-02 | No | No | Historical |
| 71335-2316-3 | 71335231603 | 40 CAPSULE in 1 BOTTLE (71335-2316-3) | 40 capsule | 2024-01-02 | No | No | Historical |
| 71335-2316-4 | 71335231604 | 60 CAPSULE in 1 BOTTLE (71335-2316-4) | 60 capsule | 2024-01-02 | No | No | Historical |
| 71335-2316-5 | 71335231605 | 20 CAPSULE in 1 BOTTLE (71335-2316-5) | 20 capsule | 2024-01-02 | No | No | Historical |
| 71335-2316-6 | 71335231606 | 100 CAPSULE in 1 BOTTLE (71335-2316-6) | 100 capsule | 2024-01-02 | No | No | Historical |
| 71335-2316-7 | 71335231607 | 180 CAPSULE in 1 BOTTLE (71335-2316-7) | 180 capsule | 2024-01-02 | No | No | Historical |
| 71335-2316-8 | 71335231608 | 120 CAPSULE in 1 BOTTLE (71335-2316-8) | 120 capsule | 2024-01-02 | No | No | Historical |
| 71335-2316-9 | 71335231609 | 10 CAPSULE in 1 BOTTLE (71335-2316-9) | 10 capsule | 2024-01-02 | No | No | Historical |