Meclizine Hydrochloride
- Product NDC
- 0904-7375
- 11-digit product format
- 009047375
- Labeler code
- 0904
- Product ID
- 0904-7375_6de99535-f55d-4353-9971-57156c334139
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Meclizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA201451
- Marketing category
- ANDA
- Marketing start
- 2022-04-22
- Substance
- MECLIZINE HYDROCHLORIDE
- Active strength
- 12.5 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 | 12.5 mg/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7375-61 | Meclizine Hydrochloride | 100 in 1 CARTON | TABLET | 100 | | 5 |
| 0904-7375-61 | Meclizine Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7375 | MECLIZINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] | 3 | Current NDC, 2 package rows | 20250214_f99f13ab-33c0-4304-8dc5-3a75f3909377.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 |
|---|
| 0904-7375-61 | 00904737561 | 100 BLISTER PACK in 1 CARTON (0904-7375-61) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2023-07-18 | No | No | Historical |