Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 71335-0311
- 11-digit product format
- 713350311
- Labeler code
- 71335
- Product ID
- 71335-0311_758bb992-fe97-4c59-aad1-7b3f7401fd47
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenoxylate Hydrochloride and Atropine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA086727
- Marketing category
- ANDA
- Marketing start
- 2017-07-07
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diphenoxylate Hydrochloride and Atropine Sulfate
- Listing expiration
- 2027-12-31
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 |
|---|
| 71335-0311-1 | Diphenoxylate Hydrochloride and Atropine Sulfate | 20 in 1 BOTTLE | TABLET | 20 | | 8 |
| 71335-0311-2 | Diphenoxylate Hydrochloride and Atropine Sulfate | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
| 71335-0311-3 | Diphenoxylate Hydrochloride and Atropine Sulfate | 15 in 1 BOTTLE | TABLET | 15 | | 8 |
| 71335-0311-4 | Diphenoxylate Hydrochloride and Atropine Sulfate | 10 in 1 BOTTLE | TABLET | 10 | | 8 |
| 71335-0311-5 | Diphenoxylate Hydrochloride and Atropine Sulfate | 40 in 1 BOTTLE | TABLET | 40 | | 8 |
| 71335-0311-6 | Diphenoxylate Hydrochloride and Atropine Sulfate | 60 in 1 BOTTLE | TABLET | 60 | | 8 |
| 71335-0311-7 | Diphenoxylate Hydrochloride and Atropine Sulfate | 90 in 1 BOTTLE | TABLET | 90 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0311 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [BRYANT RANCH PREPACK] | 7 | Current NDC, Legacy NDC, 7 package rows | 20200121_bd08ed90-dd26-4629-83c0-0f75af6ebb95.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 |
|---|
| 71335-0311-1 | 71335031101 | 20 TABLET in 1 BOTTLE (71335-0311-1) | 20 tablet | 2017-10-27 | 0000-00-00 | No | No | Current |
| 71335-0311-2 | 71335031102 | 30 TABLET in 1 BOTTLE (71335-0311-2) | 30 tablet | 2017-10-27 | 0000-00-00 | No | No | Current |
| 71335-0311-3 | 71335031103 | 15 TABLET in 1 BOTTLE (71335-0311-3) | 15 tablet | 2017-10-27 | 0000-00-00 | No | No | Current |
| 71335-0311-4 | 71335031104 | 10 TABLET in 1 BOTTLE (71335-0311-4) | 10 tablet | 2017-10-27 | 0000-00-00 | No | No | Current |
| 71335-0311-5 | 71335031105 | 40 TABLET in 1 BOTTLE (71335-0311-5) | 40 tablet | 2017-10-27 | 0000-00-00 | No | No | Current |
| 71335-0311-6 | 71335031106 | 60 TABLET in 1 BOTTLE (71335-0311-6) | 60 tablet | 2017-10-27 | 0000-00-00 | No | No | Current |
| 71335-0311-7 | 71335031107 | 90 TABLET in 1 BOTTLE (71335-0311-7) | 90 tablet | 2017-10-27 | 0000-00-00 | No | No | Current |