Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 68071-4063
- 11-digit product format
- 680714063
- Labeler code
- 68071
- Product ID
- 68071-4063_1d8dd9e3-f2b7-7894-e063-6394a90a29d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenoxylate Hydrochloride and Atropine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA086727
- Marketing category
- ANDA
- Marketing start
- 2017-06-20
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-4063-1 | 2023-05-02 | C162847 | 48780-1 | ba0f9c33-11d0-a910-e053-dadaa90a0b85 | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 68071-4063-2 | 2023-05-02 | C162847 | 48780-1 | ba0f9c33-11d0-a910-e053-dadaa90a0b85 | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 68071-4063-3 | 2023-05-02 | C162847 | 48780-1 | ba0f9c33-11d0-a910-e053-dadaa90a0b85 | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 68071-4063-5 | 2023-05-02 | C162847 | 48780-1 | ba0f9c33-11d0-a910-e053-dadaa90a0b85 | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 68071-4063-1 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-11d0-a910-e053-dadaa90a0b85 | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 68071-4063-2 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-11d0-a910-e053-dadaa90a0b85 | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 68071-4063-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-11d0-a910-e053-dadaa90a0b85 | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 68071-4063-5 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-11d0-a910-e053-dadaa90a0b85 | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 68071-4063-1 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-11d0-a910-e053-dadaa90a0b85 | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 68071-4063-2 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-11d0-a910-e053-dadaa90a0b85 | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 68071-4063-3 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-11d0-a910-e053-dadaa90a0b85 | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 68071-4063-5 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-11d0-a910-e053-dadaa90a0b85 | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 68071-4063-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-11d0-a910-e053-dadaa90a0b85 | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 68071-4063-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-11d0-a910-e053-dadaa90a0b85 | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 68071-4063-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-11d0-a910-e053-dadaa90a0b85 | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only |
| 68071-4063-5 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-11d0-a910-e053-dadaa90a0b85 | 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 |
|---|
| 68071-4063-1 | Diphenoxylate Hydrochloride and Atropine Sulfate | 10 in 1 BOTTLE | TABLET | 10 | | 6 |
| 68071-4063-2 | Diphenoxylate Hydrochloride and Atropine Sulfate | 20 in 1 BOTTLE | TABLET | 20 | | 6 |
| 68071-4063-3 | Diphenoxylate Hydrochloride and Atropine Sulfate | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 68071-4063-5 | Diphenoxylate Hydrochloride and Atropine Sulfate | 15 in 1 BOTTLE | TABLET | 15 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4063 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [NUCARE PHARMACEUTICALS,INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240720_575c38b4-7ec0-6d25-e053-2a91aa0a80fc.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 |
|---|
| 68071-4063-1 | 68071406301 | 10 TABLET in 1 BOTTLE (68071-4063-1) | 10 tablet | 2017-08-22 | 0000-00-00 | No | No | Current |
| 68071-4063-2 | 68071406302 | 20 TABLET in 1 BOTTLE (68071-4063-2) | 20 tablet | 2017-08-22 | 0000-00-00 | No | No | Current |
| 68071-4063-3 | 68071406303 | 30 TABLET in 1 BOTTLE (68071-4063-3) | 30 tablet | 2017-08-22 | 0000-00-00 | No | No | Current |
| 68071-4063-5 | 68071406305 | 15 TABLET in 1 BOTTLE (68071-4063-5) | 15 tablet | 2017-08-22 | 0000-00-00 | No | No | Current |