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NDC 63323-0842-02 Dicyclomine Hydrochloride 10 mg/mL Details
Dicyclomine Hydrochloride 10 mg/mL
Dicyclomine Hydrochloride is a INTRAMUSCULAR INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is DICYCLOMINE HYDROCHLORIDE.
Product Information
| NDC | 63323-0842 |
|---|---|
| Product ID | 63323-842_d6d9c538-e365-4e27-9371-531342f93897 |
| Associated GPIs | 49103010102005 |
| GCN Sequence Number | 004922 |
| GCN Sequence Number Description | dicyclomine HCl VIAL 10 MG/ML INTRAMUSC |
| HIC3 | J2D |
| HIC3 Description | ANTICHOLINERGICS/ANTISPASMODICS |
| GCN | 19271 |
| HICL Sequence Number | 002045 |
| HICL Sequence Number Description | DICYCLOMINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Dicyclomine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dicyclomine Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/mL |
| Substance Name | DICYCLOMINE HYDROCHLORIDE |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Anticholinergic [EPC], Cholinergic Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210257 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0842-02 (63323084202)
| NDC Package Code | 63323-842-02 |
|---|---|
| Billing NDC | 63323084202 |
| Package | 5 VIAL, SINGLE-DOSE in 1 CARTON (63323-842-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-842-21) |
| Marketing Start Date | 2019-09-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |