Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 50090-5589
- 11-digit product format
- 500905589
- Labeler code
- 50090
- Product ID
- 50090-5589_016c5145-270d-42ff-bb53-0725f9efde6f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diphenoxylate hydrochloride and atropine sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA213413
- Marketing category
- ANDA
- Marketing start
- 2020-03-15
- Substance
- ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
- Active strength
- .025; 2.5 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diphenoxylate Hydrochloride and Atropine Sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATROPINE SULFATE | .025 mg/1 |
| DIPHENOXYLATE HYDROCHLORIDE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 03J5ZE7KA5, W24OD7YW48 |
| Rxcui | 1190572 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-5589-0 | 2023-02-06 | C162847 | 48780-1 | f386c64a-1da2-0266-e053-dadaa90a7c1a | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use, C-V |
| 50090-5589-1 | 2023-02-06 | C162847 | 48780-1 | f386c64a-1da2-0266-e053-dadaa90a7c1a | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use, C-V |
| 50090-5589-2 | 2023-02-06 | C162847 | 48780-1 | f386c64a-1da2-0266-e053-dadaa90a7c1a | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use, C-V |
| 50090-5589-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1da2-0266-e053-dadaa90a7c1a | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use, C-V |
| 50090-5589-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1da2-0266-e053-dadaa90a7c1a | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use, C-V |
| 50090-5589-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1da2-0266-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 |
|---|
| 50090-5589-0 | Diphenoxylate Hydrochloride and Atropine Sulfate | 15 in 1 BOTTLE | TABLET | 15 | | 5 |
| 50090-5589-1 | Diphenoxylate Hydrochloride and Atropine Sulfate | 20 in 1 BOTTLE | TABLET | 20 | | 5 |
| 50090-5589-2 | Diphenoxylate Hydrochloride and Atropine Sulfate | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-5589 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS] | 5 | Current NDC, Legacy NDC, 3 package rows | 20241115_1be4dd7d-766c-4b3c-8b86-4f219ab44726.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 |
|---|
| 50090-5589-0 | 50090558900 | 15 TABLET in 1 BOTTLE (50090-5589-0) | 15 tablet | 2021-07-12 | 0000-00-00 | No | No | Current |
| 50090-5589-1 | 50090558901 | 20 TABLET in 1 BOTTLE (50090-5589-1) | 20 tablet | 2021-07-12 | 0000-00-00 | No | No | Current |
| 50090-5589-2 | 50090558902 | 30 TABLET in 1 BOTTLE (50090-5589-2) | 30 tablet | 2021-07-12 | 0000-00-00 | No | No | Current |