Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 53002-3400
- 11-digit product format
- 530023400
- Labeler code
- 53002
- Product ID
- 53002-3400_144b4367-53e8-46b5-be57-3d85ef76d9e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenoxylate Hydrochloride and Atropine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA086727
- Marketing category
- ANDA
- Marketing start
- 2017-07-07
- Marketing end
- 0000-00-00
- Substance
- DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE
- Active strength
- 3 mg/1; mg/1
- Pharmacologic classes
- Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-3400-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-e81e-f424-e053-dadaa90a57ce | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 53002-3400-2 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-e81e-f424-e053-dadaa90a57ce | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 53002-3400-1 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-e81e-f424-e053-dadaa90a57ce | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 53002-3400-2 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-e81e-f424-e053-dadaa90a57ce | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 53002-3400-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-e81e-f424-e053-dadaa90a57ce | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 53002-3400-2 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-e81e-f424-e053-dadaa90a57ce | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 53002-3400-1 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-e81e-f424-e053-dadaa90a57ce | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 53002-3400-2 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-e81e-f424-e053-dadaa90a57ce | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 53002-3400-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e81e-f424-e053-dadaa90a57ce | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 53002-3400-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e81e-f424-e053-dadaa90a57ce | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-3400-1 | Diphenoxylate Hydrochloride and Atropine Sulfate | 10 in 1 BOTTLE | TABLET | 10 | | 6 |
| 53002-3400-2 | Diphenoxylate Hydrochloride and Atropine Sulfate | 20 in 1 BOTTLE | TABLET | 20 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-3400 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [RPK PHARMACEUTICALS, INC.] | 6 | Legacy NDC, 2 package rows | 20230609_2a6786a1-bf8c-4f19-98c5-8119df787a21.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 |
|---|
| 53002-3400-1 | 53002340001 | 10 TABLET in 1 BOTTLE (53002-3400-1) | 10 tablet | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-3400-2 | 53002340002 | 20 TABLET in 1 BOTTLE (53002-3400-2) | 20 tablet | 2017-10-01 | 0000-00-00 | No | No | Current |