Diphenoxylate hydrochloride and atropine sulfate
- Product NDC
- 43063-957
- 11-digit product format
- 430630957
- Labeler code
- 43063
- Product ID
- 43063-957_dafc4b88-b4b4-1c1e-e053-2995a90aa3e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenoxylate hydrochloride and Atropine sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA210571
- Marketing category
- ANDA
- Marketing start
- 2018-08-31
- Marketing end
- 0000-00-00
- Substance
- ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
- Active strength
- 0 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-957-04 | 43063095704 | 4 TABLET in 1 BOTTLE, PLASTIC (43063-957-04) | 4 tablet | 2019-04-02 | 0000-00-00 | No | No | Current |
| 43063-957-10 | 43063095710 | 10 TABLET in 1 BOTTLE, PLASTIC (43063-957-10) | 10 tablet | 2019-04-02 | 0000-00-00 | No | No | Current |
| 43063-957-15 | 43063095715 | 15 TABLET in 1 BOTTLE, PLASTIC (43063-957-15) | 15 tablet | 2019-05-29 | 0000-00-00 | No | No | Current |
| 43063-957-20 | 43063095720 | 20 TABLET in 1 BOTTLE, PLASTIC (43063-957-20) | 20 tablet | 2019-03-13 | 0000-00-00 | No | No | Current |