| 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] |