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NDC 43063-0045-04 Dicyclomine Hydrochloride 20 mg/1 Details
Dicyclomine Hydrochloride 20 mg/1
Dicyclomine Hydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, Inc.. The primary component is DICYCLOMINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Dicyclomine is used to treat the symptoms of irritable bowel syndrome. Dicyclomine is in a class of medications called anticholinergics. It relieves muscle spasms in the gastrointestinal tract by blocking the activity of a certain natural substance in the body.
Related Packages: 43063-0045-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dicyclomine
Product Information
| NDC | 43063-0045 |
|---|---|
| Product ID | 43063-045_fb5bd34a-7e42-7e50-e053-6294a90ad399 |
| Associated GPIs | 49103010100305 |
| GCN Sequence Number | 004924 |
| GCN Sequence Number Description | dicyclomine HCl TABLET 20 MG ORAL |
| HIC3 | J2D |
| HIC3 Description | ANTICHOLINERGICS/ANTISPASMODICS |
| GCN | 19331 |
| 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 | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/1 |
| Substance Name | DICYCLOMINE HYDROCHLORIDE |
| Labeler Name | PD-Rx Pharmaceuticals, Inc. |
| Pharmaceutical Class | Anticholinergic [EPC], Cholinergic Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA085223 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43063-0045-04 (43063004504)
| NDC Package Code | 43063-045-04 |
|---|---|
| Billing NDC | 43063004504 |
| Package | 4 TABLET in 1 BOTTLE, PLASTIC (43063-045-04) |
| Marketing Start Date | 2008-12-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |