DICYCLOMINE HYDROCHLORIDE
- Product NDC
- 68083-320
- 11-digit product format
- 680830320
- Labeler code
- 68083
- Product ID
- 68083-320_3b7a6d2b-8d0d-45e3-9778-9a9e010aaf42
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicyclomine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Gland Pharma Limited
- Application
- ANDA210979
- Marketing category
- ANDA
- Marketing start
- 2017-12-20
- Marketing end
- 0000-00-00
- Substance
- DICYCLOMINE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Anticholinergic [EPC],Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-320-10 | 68083032010 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-320-10) > 2 mL in 1 VIAL, SINGLE-DOSE (68083-320-01) | 2017-12-20 | 0000-00-00 | No | No | Current |