Lofexidine
- Product NDC
- 70954-909
- 11-digit product format
- 709540909
- Labeler code
- 70954
- Product ID
- 70954-909_335e26bf-b236-46d6-81cf-2879e5f3b1d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lofexidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA219917
- Marketing category
- ANDA
- Marketing start
- 2025-10-22
- Substance
- LOFEXIDINE HYDROCHLORIDE
- Active strength
- .18 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lofexidine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOFEXIDINE HYDROCHLORIDE | .18 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V47G1SDI1B |
| Rxcui | 2046591 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-909-10 | Lofexidine | 36 in 1 BOTTLE | TABLET | 36 | | 1 |
| 70954-909-20 | Lofexidine | 96 in 1 BOTTLE | TABLET | 96 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70954-909-10 | 70954090910 | 36 TABLET in 1 BOTTLE (70954-909-10) | 36 tablet | 2025-10-22 | No | No | Historical |
| 70954-909-20 | 70954090920 | 96 TABLET in 1 BOTTLE (70954-909-20) | 96 tablet | 2025-10-22 | No | No | Historical |