DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Product NDC
- 72189-336
- 11-digit product format
- 721890336
- Labeler code
- 72189
- Product ID
- 72189-336_2c3d9a97-2f79-1c66-e063-6294a90ab5c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct Rx
- Application
- ANDA213413
- Marketing category
- ANDA
- Marketing start
- 2022-03-07
- 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
- 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 |
|---|
| 72189-336-10 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 10 in 1 BOTTLE | TABLET | 10 | | 5 |
| 72189-336-30 | 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 |
|---|
| 72189-336 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DIRECT RX] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250122_d9a36478-4788-4107-e053-2a95a90ad6da.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 |
|---|
| 72189-336-10 | 72189033610 | 10 TABLET in 1 BOTTLE (72189-336-10) | 10 tablet | 2022-03-07 | 0000-00-00 | No | No | Current |
| 72189-336-30 | 72189033630 | 30 TABLET in 1 BOTTLE (72189-336-30) | 30 tablet | 2022-03-07 | 0000-00-00 | No | No | Current |