Lucemyra
- Product NDC
- 78670-050
- 11-digit product format
- 786700050
- Labeler code
- 78670
- Product ID
- 78670-050_0be33ddd-71d6-45b7-85ce-e665789911ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lofexidine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- USWM, LLC
- Application
- NDA209229
- Marketing category
- NDA
- Marketing start
- 2021-02-09
- Marketing end
- 2026-08-31
- Substance
- LOFEXIDINE HYDROCHLORIDE
- Active strength
- .2 mg/1
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lucemyra
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOFEXIDINE HYDROCHLORIDE | .2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V47G1SDI1B |
| Rxcui | 2046591, 2046597 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 78670-050-03 | Lucemyra | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 9 |
| 78670-050-03 | Lucemyra | 36 in 1 BOTTLE | TABLET, FILM COATED | 36 | | 9 |
| 78670-050-36 | Lucemyra | 36 in 1 BOTTLE | TABLET, FILM COATED | 36 | | 9 |
| 78670-050-36 | Lucemyra | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 9 |
| 78670-050-96 | Lucemyra | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 9 |
| 78670-050-96 | Lucemyra | 96 in 1 BOTTLE | TABLET, FILM COATED | 96 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 78670-050 | LUCEMYRA (LOFEXIDINE HYDROCHLORIDE) TABLET, FILM COATED [USWM, LLC] | 7 | Current NDC, Legacy NDC, 6 package rows | 20240921_b748f308-ba71-4fd9-84ec-ec7e0f210885.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 |
|---|
| 78670-050-03 | 78670005003 | 1 BOTTLE in 1 CARTON (78670-050-03) / 36 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-02-09 | 2026-08-31 | No | No | Current |
| 78670-050-36 | 78670005036 | 1 BOTTLE in 1 CARTON (78670-050-36) / 36 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-02-09 | 2026-08-31 | No | No | Current |
| 78670-050-96 | 78670005096 | 1 BOTTLE in 1 CARTON (78670-050-96) / 96 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-02-09 | 2026-08-31 | No | No | Current |