Product NDC: | 58914-080 |
Proprietary Name: | Bentyl |
Non Proprietary Name: | Dicyclomine hydrochloride |
Active Ingredient(s): | 20 mg/2mL & nbsp; Dicyclomine hydrochloride |
Administration Route(s): | INTRAMUSCULAR |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 58914-080 |
Labeler Name: | Aptalis Pharma US, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA008370 |
Marketing Category: | NDA |
Start Marketing Date: | 19520813 |
Package NDC: | 58914-080-52 |
Package Description: | 5 AMPULE in 1 BOX (58914-080-52) > 2 mL in 1 AMPULE |
NDC Code | 58914-080-52 |
Proprietary Name | Bentyl |
Package Description | 5 AMPULE in 1 BOX (58914-080-52) > 2 mL in 1 AMPULE |
Product NDC | 58914-080 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Dicyclomine hydrochloride |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAMUSCULAR |
Start Marketing Date | 19520813 |
Marketing Category Name | NDA |
Labeler Name | Aptalis Pharma US, Inc. |
Substance Name | DICYCLOMINE HYDROCHLORIDE |
Strength Number | 20 |
Strength Unit | mg/2mL |
Pharmaceutical Classes | Anticholinergic [EPC],Cholinergic Antagonists [MoA] |