Motofen
- Product NDC
- 83107-011
- 11-digit product format
- 831070011
- Labeler code
- 83107
- Product ID
- 83107-011_4db25dab-3394-5f06-e063-6294a90a9688
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- difenoxin and atropine sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Legacy Pharma USA Inc.
- Application
- NDA017744
- Marketing category
- NDA
- Marketing start
- 2026-01-01
- Substance
- ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE
- Active strength
- .025; 1 mg/1; mg/1
- Pharmacologic classes
- Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Motofen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATROPINE SULFATE | .025 mg/1 |
| DIFENOXIN HYDROCHLORIDE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 03J5ZE7KA5, VQZ63K01IW |
| Rxcui | 1190738, 1190740 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83107-011-10 | Motofen | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83107-011-10 | 83107001110 | 100 TABLET in 1 BOTTLE (83107-011-10) | 100 tablet | 2026-01-01 | No | No | Historical |