Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 63187-939
- 11-digit product format
- 631870939
- Labeler code
- 63187
- Product ID
- 63187-939_397aa3b9-b2ba-44d0-92a4-b63cedc333cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenoxylate Hydrochloride and Atropine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- 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
- 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 |
|---|
| 63187-939-10 | Diphenoxylate Hydrochloride and Atropine Sulfate | 10 in 1 BOTTLE | TABLET | 10 | | 4 |
| 63187-939-15 | Diphenoxylate Hydrochloride and Atropine Sulfate | 15 in 1 BOTTLE | TABLET | 15 | | 4 |
| 63187-939-20 | Diphenoxylate Hydrochloride and Atropine Sulfate | 20 in 1 BOTTLE | TABLET | 20 | | 4 |
| 63187-939-30 | Diphenoxylate Hydrochloride and Atropine Sulfate | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 63187-939-60 | Diphenoxylate Hydrochloride and Atropine Sulfate | 60 in 1 BOTTLE | TABLET | 60 | | 4 |
| 63187-939-90 | Diphenoxylate Hydrochloride and Atropine Sulfate | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-939 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [PROFICIENT RX LP] | 4 | Current NDC, Legacy NDC, 6 package rows | 20200313_c832ef16-a06e-4e47-9df3-ab33bdfa6e56.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 |
|---|
| 63187-939-10 | 63187093910 | 10 TABLET in 1 BOTTLE (63187-939-10) | 10 tablet | 2017-12-01 | 0000-00-00 | No | No | Current |
| 63187-939-15 | 63187093915 | 15 TABLET in 1 BOTTLE (63187-939-15) | 15 tablet | 2017-12-01 | 0000-00-00 | No | No | Current |
| 63187-939-20 | 63187093920 | 20 TABLET in 1 BOTTLE (63187-939-20) | 20 tablet | 2017-12-01 | 0000-00-00 | No | No | Current |
| 63187-939-30 | 63187093930 | 30 TABLET in 1 BOTTLE (63187-939-30) | 30 tablet | 2017-12-01 | 0000-00-00 | No | No | Current |
| 63187-939-60 | 63187093960 | 60 TABLET in 1 BOTTLE (63187-939-60) | 60 tablet | 2017-12-01 | 0000-00-00 | No | No | Current |
| 63187-939-90 | 63187093990 | 90 TABLET in 1 BOTTLE (63187-939-90) | 90 tablet | 2017-12-01 | 0000-00-00 | No | No | Current |