Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 59762-1061
- 11-digit product format
- 597621061
- Labeler code
- 59762
- Product ID
- 59762-1061_b4b0055f-415c-49fa-9c67-cc600ac024be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenoxylate Hydrochloride and Atropine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA012462
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2012-08-07
- Marketing end
- 2026-11-30
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diphenoxylate Hydrochloride and Atropine Sulfate
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ATROPINE SULFATE | .025 mg/1 |
| DIPHENOXYLATE HYDROCHLORIDE | 2.5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 03J5ZE7KA5, W24OD7YW48 |
| Rxcui | 1190572 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c78bd43-efb4-4aeb-b7d8-eff1532f7822 | Product name | 4 | 20250801 |
| 41231c1e-8789-4da7-ac52-77fa90a85bf5 | Product name | 2 | 20250304 |
| e77ab9a2-80cf-4832-bff0-469bbc7cbcd0 | Product name | 2 | 20250214 |
| 5f84b7a7-523a-f042-dffb-1dadcd9b2407 | Product name | 4 | 20240110 |
| 0cbc6fb2-78c0-4b88-98f0-a4cc76ff95ca | Product name | 1 | 20230719 |
| 04cd5dc0-102f-46cb-8dbc-ca38dd2628d0 | Product name | 3 | 20230317 |
| dfd25202-b8d2-4628-9213-f3e0f9eafce5 | Product name | 4 | 20210513 |
| 4199bf9b-4718-828a-6dd6-ac2fbbd61687 | Product name | 1 | 20140508 |
| 4edd8af5-cea7-ae42-8023-e91c5335db1d | Product name | 1 | 20140508 |
| d3908afb-7784-440f-c406-88294732d36a | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59762-1061-1 | Diphenoxylate Hydrochloride and Atropine Sulfate | 100 in 1 BOTTLE | TABLET | 100 | 11 | |
| 59762-1061-2 | Diphenoxylate Hydrochloride and Atropine Sulfate | 1000 in 1 BOTTLE | TABLET | 1000 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59762-1061-1 | EA - Each | 59762-1061 | 623b343e-37e7-479a-94b5-cfb116044041 | 1 | 2012-07-24 |
| 59762-1061-2 | EA - Each | 59762-1061 | dfb2e6a3-3875-45b5-b72a-7284a5b6716a | 1 | 2013-03-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59762-1061 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [MYLAN PHARMACEUTICALS INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250522_83bcc2fb-6fb0-4f0e-8e66-592d327684ec.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1190572 | diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet | PSN | f3e23860-264c-4a93-aa78-0722cd5187ab | 12 |
| 1190572 | atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet | SCD | f3e23860-264c-4a93-aa78-0722cd5187ab | 12 |
| 1190572 | diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet | PSN | 83bcc2fb-6fb0-4f0e-8e66-592d327684ec | 11 |
| 1190572 | diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet | PSN | aae3896d-0e79-480d-8a9d-a12ff2e0318a | 11 |
| 1190572 | atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet | SCD | 83bcc2fb-6fb0-4f0e-8e66-592d327684ec | 11 |
| 1190572 | atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet | SCD | aae3896d-0e79-480d-8a9d-a12ff2e0318a | 11 |
| 1190572 | diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet | PSN | 4f457a86-b920-5b53-e054-00144ff8d46c | 4 |
| 1190572 | atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet | SCD | 4f457a86-b920-5b53-e054-00144ff8d46c | 4 |
| 1190572 | diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet | PSN | dec09873-1ccc-4efe-918d-337b3926384d | 3 |
| 1190572 | atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet | SCD | dec09873-1ccc-4efe-918d-337b3926384d | 3 |
| 1190572 | diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet | PSN | 8c59e8c6-4fc0-4c30-95ab-740b84e352e1 | 2 |
| 1190572 | atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet | SCD | 8c59e8c6-4fc0-4c30-95ab-740b84e352e1 | 2 |
| 1190572 | diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet | PSN | 59934cee-4e1f-4958-9e97-6de53b39daf3 | 1 |
| 1190572 | atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet | SCD | 59934cee-4e1f-4958-9e97-6de53b39daf3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59762-1061-1 | 59762106101 | 100 TABLET in 1 BOTTLE (59762-1061-1) | 100 tablet | 2012-08-07 | 2026-11-30 | No | No | Current |
| 59762-1061-2 | 59762106102 | 1000 TABLET in 1 BOTTLE (59762-1061-2) | 1000 tablet | 2013-03-06 | 0000-00-00 | No | No | Current |