Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 71610-714
- 11-digit product format
- 716100714
- Labeler code
- 71610
- Product ID
- 71610-714_d2906ede-d6cd-449f-83ac-a087b2cec958
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diphenoxylate hydrochloride and atropine sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA213335
- Marketing category
- ANDA
- Marketing start
- 2020-10-30
- 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 |
|---|
| 71610-714-30 | Diphenoxylate Hydrochloride and Atropine Sulfate | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 71610-714-53 | Diphenoxylate Hydrochloride and Atropine Sulfate | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 71610-714-60 | Diphenoxylate Hydrochloride and Atropine Sulfate | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
| 71610-714-70 | Diphenoxylate Hydrochloride and Atropine Sulfate | 120 in 1 BOTTLE | TABLET | 120 | | 1 |
| 71610-714-80 | Diphenoxylate Hydrochloride and Atropine Sulfate | 180 in 1 BOTTLE | TABLET | 180 | | 1 |
| 71610-714-90 | 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 |
|---|
| 71610-714 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, 6 package rows | 20230615_c11574c7-8344-4987-85ef-f2404daa0885.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-714-30 | 71610071430 | 30 TABLET in 1 BOTTLE (71610-714-30) | 30 tablet | 2023-06-12 | No | No | Historical |
| 71610-714-53 | 71610071453 | 60 TABLET in 1 BOTTLE (71610-714-53) | 60 tablet | 2023-06-12 | No | No | Historical |
| 71610-714-60 | 71610071460 | 90 TABLET in 1 BOTTLE (71610-714-60) | 90 tablet | 2023-06-12 | No | No | Historical |
| 71610-714-70 | 71610071470 | 120 TABLET in 1 BOTTLE (71610-714-70) | 120 tablet | 2023-06-12 | No | No | Historical |
| 71610-714-80 | 71610071480 | 180 TABLET in 1 BOTTLE (71610-714-80) | 180 tablet | 2023-06-12 | No | No | Historical |
| 71610-714-90 | 71610071490 | 240 TABLET in 1 BOTTLE (71610-714-90) | 240 tablet | 2023-06-12 | No | No | Historical |