Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 43353-594
- 11-digit product format
- 433530594
- Labeler code
- 43353
- Product ID
- 43353-594_ef69e563-7239-4c78-8fb4-3cd641fbff17
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenoxylate Hydrochloride and Atropine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA086727
- Marketing category
- ANDA
- Marketing start
- 2017-06-20
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-594-30 | Diphenoxylate Hydrochloride and Atropine Sulfate | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 43353-594-53 | Diphenoxylate Hydrochloride and Atropine Sulfate | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 43353-594-60 | Diphenoxylate Hydrochloride and Atropine Sulfate | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
| 43353-594-70 | Diphenoxylate Hydrochloride and Atropine Sulfate | 120 in 1 BOTTLE | TABLET | 120 | | 1 |
| 43353-594-80 | Diphenoxylate Hydrochloride and Atropine Sulfate | 180 in 1 BOTTLE | TABLET | 180 | | 1 |
| 43353-594-90 | Diphenoxylate Hydrochloride and Atropine Sulfate | 240 in 1 BOTTLE | TABLET | 240 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-594 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 6 package rows | 20171003_435e5e75-5a4c-4806-8d9e-d4be3fef9229.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 |
|---|
| 43353-594-30 | 43353059430 | 30 TABLET in 1 BOTTLE (43353-594-30) | 30 tablet | 2017-07-26 | 0000-00-00 | No | No | Current |
| 43353-594-53 | 43353059453 | 60 TABLET in 1 BOTTLE (43353-594-53) | 60 tablet | 2017-07-26 | 0000-00-00 | No | No | Current |
| 43353-594-60 | 43353059460 | 90 TABLET in 1 BOTTLE (43353-594-60) | 90 tablet | 2017-07-26 | 0000-00-00 | No | No | Current |
| 43353-594-70 | 43353059470 | 120 TABLET in 1 BOTTLE (43353-594-70) | 120 tablet | 2017-07-26 | 0000-00-00 | No | No | Current |
| 43353-594-80 | 43353059480 | 180 TABLET in 1 BOTTLE (43353-594-80) | 180 tablet | 2017-07-26 | 0000-00-00 | No | No | Current |
| 43353-594-90 | 43353059490 | 240 TABLET in 1 BOTTLE (43353-594-90) | 240 tablet | 2017-07-26 | 0000-00-00 | No | No | Current |