Lofexidine
- Product NDC
- 14445-146
- 11-digit product format
- 144450146
- Labeler code
- 14445
- Product ID
- 14445-146_d60a5ecb-5e15-4ea7-bc53-a3740f00adff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lofexidine
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Indoco Remedies Limited
- Application
- ANDA218613
- Marketing category
- ANDA
- Marketing start
- 2024-08-21
- 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 |
|---|
| 14445-146-36 | Lofexidine | 1 in 1 CARTON | TABLET, COATED | 1 | | 3 |
| 14445-146-36 | Lofexidine | 36 in 1 BOTTLE | TABLET, COATED | 36 | | 3 |
| 14445-146-96 | Lofexidine | 96 in 1 BOTTLE | TABLET, COATED | 96 | | 3 |
| 14445-146-96 | Lofexidine | 1 in 1 CARTON | TABLET, COATED | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 14445-146 | LOFEXIDINE TABLET, COATED [INDOCO REMEDIES LIMITED ] | 3 | Current NDC, 4 package rows | 20240822_ed7613f5-ac52-4108-afb7-d92c818d6e3c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 14445-146-36 | 14445014636 | 1 BOTTLE in 1 CARTON (14445-146-36) / 36 TABLET, COATED in 1 BOTTLE | 1 bottle | 2024-08-21 | No | No | Historical |
| 14445-146-96 | 14445014696 | 1 BOTTLE in 1 CARTON (14445-146-96) / 96 TABLET, COATED in 1 BOTTLE | 1 bottle | 2024-08-21 | No | No | Historical |