Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 71205-909
- 11-digit product format
- 712050909
- Labeler code
- 71205
- Product ID
- 71205-909_d6e4b4d5-8bf3-4e39-a1ad-c3ccca5fcab2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diphenoxylate hydrochloride and atropine sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71205-909-00 | Diphenoxylate Hydrochloride and Atropine Sulfate | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 71205-909-11 | Diphenoxylate Hydrochloride and Atropine Sulfate | 1000 in 1 BOTTLE | TABLET | 1000 | | 2 |
| 71205-909-30 | Diphenoxylate Hydrochloride and Atropine Sulfate | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 71205-909-55 | Diphenoxylate Hydrochloride and Atropine Sulfate | 500 in 1 BOTTLE | TABLET | 500 | | 2 |
| 71205-909-60 | Diphenoxylate Hydrochloride and Atropine Sulfate | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
| 71205-909-90 | Diphenoxylate Hydrochloride and Atropine Sulfate | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-909 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [PROFICIENT RX LP] | 2 | Current NDC, Legacy NDC, 6 package rows | 20220331_593f2d01-5d24-450e-a6cf-204b7420f971.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 |
|---|
| 71205-909-00 | 71205090900 | 100 TABLET in 1 BOTTLE (71205-909-00) | 100 tablet | 2021-07-16 | 0000-00-00 | No | No | Current |
| 71205-909-11 | 71205090911 | 1000 TABLET in 1 BOTTLE (71205-909-11) | 1000 tablet | 2021-07-16 | 0000-00-00 | No | No | Current |
| 71205-909-30 | 71205090930 | 30 TABLET in 1 BOTTLE (71205-909-30) | 30 tablet | 2021-07-16 | 0000-00-00 | No | No | Current |
| 71205-909-55 | 71205090955 | 500 TABLET in 1 BOTTLE (71205-909-55) | 500 tablet | 2021-07-16 | 0000-00-00 | No | No | Current |
| 71205-909-60 | 71205090960 | 60 TABLET in 1 BOTTLE (71205-909-60) | 60 tablet | 2021-07-16 | 0000-00-00 | No | No | Current |
| 71205-909-90 | 71205090990 | 90 TABLET in 1 BOTTLE (71205-909-90) | 90 tablet | 2021-07-16 | 0000-00-00 | No | No | Current |