Meclizine Hydrochloride
- Product NDC
- 68788-8633
- 11-digit product format
- 687888633
- Labeler code
- 68788
- Product ID
- 68788-8633_769c5aef-cef1-4cd7-a775-3facb91cc01f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Meclizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- NDA010721
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2024-04-16
- Substance
- MECLIZINE HYDROCHLORIDE
- Active strength
- 12.5 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 | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HDP7W44CIO |
| Rxcui | 995624 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8633-1 | Meclizine Hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | | 2 |
| 68788-8633-3 | Meclizine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8633 | MECLIZINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 2 package rows | 20240420_d7d31433-8f39-4fe6-b542-1b4410122db7.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 |
|---|
| 68788-8633-1 | 68788863301 | 10 TABLET in 1 BOTTLE (68788-8633-1) | 10 tablet | 2024-04-16 | No | No | Historical |
| 68788-8633-3 | 68788863303 | 30 TABLET in 1 BOTTLE (68788-8633-3) | 30 tablet | 2024-04-16 | No | No | Historical |