Meclizine Hydrochloride
- Product NDC
- 42806-012
- 11-digit product format
- 428060012
- Labeler code
- 42806
- Product ID
- 42806-012_42600718-075b-481b-8fec-cb6cbadab7de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Meclizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Epic Pharma LLC
- Application
- ANDA200294
- Marketing category
- ANDA
- Marketing start
- 2012-04-30
- 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, 995666 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42806-012-01 | Meclizine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 12 |
| 42806-012-10 | Meclizine Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MECLIZINE HYDROCHLORIDE | ACTIVE INGREDIENT | HDP7W44CIO | MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 6 | |
| MECLIZINE | ACTIVE MOIETY | 3L5TQ84570 | MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 6 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 6 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-012 | MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA LLC] | 12 | Current NDC, Legacy NDC, 2 package rows | 20200822_467e464b-bbaf-4053-9136-39e47a92fa05.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 |
|---|
| 42806-012-01 | 42806001201 | 100 TABLET in 1 BOTTLE (42806-012-01) | 100 tablet | 2012-04-30 | 0000-00-00 | No | No | Current |
| 42806-012-10 | 42806001210 | 1000 TABLET in 1 BOTTLE (42806-012-10) | 1000 tablet | 2012-04-30 | 0000-00-00 | No | No | Current |