Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 75826-107
- 11-digit product format
- 758260107
- Labeler code
- 75826
- Product ID
- 75826-107_2b0ecbe9-ac10-5211-e063-6394a90a123e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenoxylate Hydrochloride and Atropine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Winder Laboratories LLC
- Application
- ANDA211362
- Marketing category
- ANDA
- Marketing start
- 2022-04-30
- 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 |
|---|
| 75826-107-00 | Diphenoxylate Hydrochloride and Atropine Sulfate | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 9 |
| 75826-107-03 | Diphenoxylate Hydrochloride and Atropine Sulfate | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 9 |
| 75826-107-11 | Diphenoxylate Hydrochloride and Atropine Sulfate | 10 in 1 BOTTLE, PLASTIC | TABLET | 10 | | 9 |
| 75826-107-33 | Diphenoxylate Hydrochloride and Atropine Sulfate | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 9 |
| 75826-107-90 | Diphenoxylate Hydrochloride and Atropine Sulfate | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75826-107 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [WINDER LABORATORIES LLC] | 9 | Current NDC, Legacy NDC, 5 package rows | 20250108_7344a2d2-1f8a-4c5a-90e3-181b919c0c7a.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 |
|---|
| 75826-107-00 | 75826010700 | 1000 TABLET in 1 BOTTLE, PLASTIC (75826-107-00) | 1000 tablet | 2022-09-01 | 0000-00-00 | No | No | Current |
| 75826-107-03 | 75826010703 | 100 TABLET in 1 BOTTLE, PLASTIC (75826-107-03) | 100 tablet | 2022-09-01 | 0000-00-00 | No | No | Current |
| 75826-107-10 | 75826010710 | 10 TABLET in 1 BOTTLE, PLASTIC (75826-107-10) | 10 tablet | 2021-02-08 | 0000-00-00 | No | No | Current |
| 75826-107-11 | 75826010711 | 10 TABLET in 1 BOTTLE, PLASTIC (75826-107-11) | 10 tablet | 2022-09-01 | 0000-00-00 | No | No | Current |
| 75826-107-20 | 75826010720 | 30 TABLET in 1 BOTTLE, PLASTIC (75826-107-20) | 30 tablet | 2021-02-08 | 0000-00-00 | No | No | Current |
| 75826-107-30 | 75826010730 | 100 TABLET in 1 BOTTLE, PLASTIC (75826-107-30) | 100 tablet | 2021-02-08 | 0000-00-00 | No | No | Current |
| 75826-107-33 | 75826010733 | 30 TABLET in 1 BOTTLE, PLASTIC (75826-107-33) | 30 tablet | 2022-09-01 | 0000-00-00 | No | No | Current |
| 75826-107-40 | 75826010740 | 1000 TABLET in 1 BOTTLE, PLASTIC (75826-107-40) | 1000 tablet | 2021-02-08 | 0000-00-00 | No | No | Current |
| 75826-107-90 | 75826010790 | 90 TABLET in 1 BOTTLE, PLASTIC (75826-107-90) | 90 tablet | 2022-09-01 | 0000-00-00 | No | No | Current |