Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 76385-107
- 11-digit product format
- 763850107
- Labeler code
- 76385
- Product ID
- 76385-107_606720c6-e55e-4338-b18a-1e1b5018ab7d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenoxylate Hydrochloride and Atropine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA210819
- Marketing category
- ANDA
- Marketing start
- 2019-05-15
- 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 |
|---|
| 76385-107-01 | Diphenoxylate Hydrochloride and Atropine Sulfate | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 76385-107-10 | Diphenoxylate Hydrochloride and Atropine Sulfate | 1000 in 1 BOTTLE | TABLET | 1000 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76385-107 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [BAYSHORE PHARMACEUTICALS, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240110_5117f26c-488f-4ba6-b115-22baf12557f3.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 |
|---|
| 76385-107-01 | 76385010701 | 100 TABLET in 1 BOTTLE (76385-107-01) | 100 tablet | 2019-05-15 | 0000-00-00 | No | No | Current |
| 76385-107-10 | 76385010710 | 1000 TABLET in 1 BOTTLE (76385-107-10) | 1000 tablet | 2019-05-15 | 0000-00-00 | No | No | Current |