Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 70518-3513
- 11-digit product format
- 705183513
- Labeler code
- 70518
- Product ID
- 70518-3513_eff3c6e6-bdfc-4068-e053-2a95a90aa274
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenoxylate Hydrochloride and Atropine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA086727
- Marketing category
- ANDA
- Marketing start
- 2022-09-07
- 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 |
|---|
| 70518-3513-0 | 70518351300 | 30 TABLET in 1 BLISTER PACK (70518-3513-0) | 30 tablet | 2022-09-07 | 0000-00-00 | No | No | Current |