Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 68071-2328
- 11-digit product format
- 680712328
- Labeler code
- 68071
- Product ID
- 68071-2328_b8a2af11-dede-538f-e053-2995a90afc0c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diphenoxylate hydrochloride and atropine sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA213413
- Marketing category
- ANDA
- Marketing start
- 2020-03-15
- 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
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-2328-1 | 2025-01-30 | C162847 | 48780-1 | f386c649-a5fb-0266-e053-dadaa90a7c1a | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use, C-V |
| 68071-2328-3 | 2025-01-30 | C162847 | 48780-1 | f386c649-a5fb-0266-e053-dadaa90a7c1a | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use, C-V |
| 68071-2328-1 | 2023-12-06 | C162847 | 48780-1 | f386c649-a5fb-0266-e053-dadaa90a7c1a | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use, C-V |
| 68071-2328-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-a5fb-0266-e053-dadaa90a7c1a | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use, C-V |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-2328-1 | Diphenoxylate Hydrochloride and Atropine Sulfate | 10 in 1 BOTTLE | TABLET | 10 | | 2 |
| 68071-2328-3 | Diphenoxylate Hydrochloride and Atropine Sulfate | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2328 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [NUCARE PHARMACEUTICALS,INC.] | 2 | Legacy NDC, 2 package rows | 20231207_b8a2a78a-67ae-50a5-e053-2a95a90ad9a7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-2328-1 | 68071232801 | 10 TABLET in 1 BOTTLE (68071-2328-1) | 10 tablet | 2021-01-11 | 0000-00-00 | No | No | Current |
| 68071-2328-3 | 68071232803 | 30 in 1 BOTTLE | | | | | | Historical |