Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 51293-618
- 11-digit product format
- 512930618
- Labeler code
- 51293
- Product ID
- 51293-618_df4e0622-3d00-5cec-e053-2a95a90ac345
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenoxylate Hydrochloride and Atropine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ECI Pharmaceuticals, LLC
- Application
- ANDA207128
- Marketing category
- ANDA
- Marketing start
- 2020-10-21
- 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
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51293-618-00 | 51293061800 | 1 BAG in 1 DRUM (51293-618-00) > 1 BAG in 1 BAG > 125000 TABLET in 1 BAG | 1 bag | 2022-05-17 | 0000-00-00 | No | No | Current |
| 51293-618-01 | 51293061801 | 100 TABLET in 1 BOTTLE (51293-618-01) | 100 tablet | 2020-10-21 | 0000-00-00 | No | No | Current |
| 51293-618-10 | 51293061810 | 1000 TABLET in 1 BOTTLE (51293-618-10) | 1000 tablet | 2020-10-21 | 0000-00-00 | No | No | Current |
| 51293-618-64 | 51293061864 | 30 TABLET in 1 BOTTLE (51293-618-64) | 30 tablet | 2020-10-21 | 0000-00-00 | No | No | Current |