MECLIZINE HYDROCHLORIDE
- Product NDC
- 59651-809
- 11-digit product format
- 596510809
- Labeler code
- 59651
- Product ID
- 59651-809_beb3c7f2-c0f4-41d9-a903-63a6847e0997
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MECLIZINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA202640
- Marketing category
- ANDA
- Marketing start
- 2023-09-14
- Substance
- MECLIZINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Antiemetic [EPC], Emesis Suppression [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MECLIZINE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MECLIZINE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HDP7W44CIO |
| Rxcui | 995624, 995666, 995686 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-809-05 | MECLIZINE HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET | 500 | | 1 |
| 59651-809-90 | MECLIZINE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-809 | MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET [AUROBINDO PHARMA LIMITED] | 1 | Current NDC, 2 package rows | 20230920_beb3c7f2-c0f4-41d9-a903-63a6847e0997.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 |
|---|
| 59651-809-05 | 59651080905 | 500 TABLET in 1 BOTTLE (59651-809-05) | 500 tablet | 2023-09-14 | No | No | Historical |
| 59651-809-90 | 59651080990 | 90 TABLET in 1 BOTTLE (59651-809-90) | 90 tablet | 2023-09-14 | No | No | Historical |