Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 71335-1693
- 11-digit product format
- 713351693
- Labeler code
- 71335
- Product ID
- 71335-1693_30c2b613-bd3c-46d0-b344-cf46d7a9c616
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diphenoxylate hydrochloride and atropine sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA213413
- Marketing category
- ANDA
- Marketing start
- 2020-03-15
- Substance
- ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
- Active strength
- .025; 2.5 mg/1; mg/1
- Pharmacologic classes
- Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 03J5ZE7KA5 | ATROPINE SULFATE | 5908-99-6 | ATROPINE SULFATE |
| W24OD7YW48 | DIPHENOXYLATE HYDROCHLORIDE | 3810-80-8 | DIPHENOXYLATE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-1693-1 | 71335169301 | 20 TABLET in 1 BOTTLE (71335-1693-1) | 20 tablet | 2020-10-13 | No | No | Historical |
| 71335-1693-2 | 71335169302 | 30 TABLET in 1 BOTTLE (71335-1693-2) | 30 tablet | 2020-12-10 | No | No | Historical |
| 71335-1693-3 | 71335169303 | 15 TABLET in 1 BOTTLE (71335-1693-3) | 15 tablet | 2021-12-29 | No | No | Historical |
| 71335-1693-4 | 71335169304 | 10 TABLET in 1 BOTTLE (71335-1693-4) | 10 tablet | 2020-09-03 | No | No | Historical |
| 71335-1693-5 | 71335169305 | 40 TABLET in 1 BOTTLE (71335-1693-5) | 40 tablet | 2021-12-29 | No | No | Historical |
| 71335-1693-6 | 71335169306 | 60 TABLET in 1 BOTTLE (71335-1693-6) | 60 tablet | 2021-12-29 | No | No | Historical |
| 71335-1693-7 | 71335169307 | 90 TABLET in 1 BOTTLE (71335-1693-7) | 90 tablet | 2021-12-29 | No | No | Historical |