Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 55289-102
- 11-digit product format
- 552890102
- Labeler code
- 55289
- Product ID
- 55289-102_d231296a-49ab-b2c3-e053-2a95a90a815e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diphenoxylate hydrochloride and atropine sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA085762
- Marketing category
- ANDA
- Marketing start
- 1977-11-17
- Marketing end
- 0000-00-00
- Substance
- DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE
- Active strength
- 3 mg/1; mg/1
- Pharmacologic classes
- Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 55289-102-10 | 55289010210 | 10 TABLET in 1 BOTTLE, PLASTIC (55289-102-10) | 10 tablet | 2009-11-19 | 0000-00-00 | No | No | Current |
| 55289-102-15 | 55289010215 | 15 TABLET in 1 BOTTLE, PLASTIC (55289-102-15) | 15 tablet | 2017-11-07 | 0000-00-00 | No | No | Current |
| 55289-102-20 | 55289010220 | 20 TABLET in 1 BOTTLE, PLASTIC (55289-102-20) | 20 tablet | 2009-11-19 | 0000-00-00 | No | No | Current |
| 55289-102-30 | 55289010230 | 30 TABLET in 1 BOTTLE, PLASTIC (55289-102-30) | 30 tablet | 2009-11-19 | 0000-00-00 | No | No | Current |