Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 66336-437
- 11-digit product format
- 663360437
- Labeler code
- 66336
- Product ID
- 66336-437_7da07df7-0b87-4c0d-9600-1d9189391587
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diphenoxylate hydrochloride and atropine sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dispensing Solutions, Inc.
- Application
- ANDA085762
- Marketing category
- ANDA
- Marketing start
- 2010-11-30
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66336-437-15 | Diphenoxylate Hydrochloride and Atropine Sulfate | 15 in 1 BOTTLE | TABLET | 15 | | 1 |
| 66336-437-20 | Diphenoxylate Hydrochloride and Atropine Sulfate | 20 in 1 BOTTLE | TABLET | 20 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ATROPINE SULFATE | ACTIVE INGREDIENT | 03J5ZE7KA5 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| DIPHENOXYLATE HYDROCHLORIDE | ACTIVE INGREDIENT | W24OD7YW48 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| ATROPINE | ACTIVE MOIETY | 7C0697DR9I | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| DIPHENOXYLATE | ACTIVE MOIETY | 73312P173G | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66336-437 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 2 package rows | 20120221_47b65bb8-8501-448c-aecd-b41c8efb4241.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 66336-437-15 | 66336043715 | 15 in 1 BOTTLE | Historical |
| 66336-437-20 | 66336043720 | 20 in 1 BOTTLE | Historical |