Meclizine Hydrochloride
- Product NDC
- 82868-058
- 11-digit product format
- 828680058
- Labeler code
- 82868
- Product ID
- 82868-058_476cb2cb-26c4-af46-e063-6394a90a2915
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Meclizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA201451
- Marketing category
- ANDA
- Marketing start
- 2024-06-11
- Substance
- MECLIZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Antiemetic [EPC], Emesis Suppression [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Meclizine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MECLIZINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HDP7W44CIO |
| Rxcui | 995666 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82868-058-20 | Meclizine Hydrochloride | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | | 3 |
| 82868-058-30 | Meclizine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82868-058 | MECLIZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 2 package rows | 20240627_1b541252-e8a7-b678-e063-6394a90a34dc.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 |
|---|
| 82868-058-20 | 82868005820 | 20 TABLET in 1 BOTTLE, PLASTIC (82868-058-20) | 20 tablet | 2025-06-27 | No | No | Historical |
| 82868-058-30 | 82868005830 | 30 TABLET in 1 BOTTLE, PLASTIC (82868-058-30) | 30 tablet | 2024-06-11 | No | No | Historical |