HYDROXYZINE HYDROCHLORIDE
- Product NDC
- 10135-812
- 11-digit product format
- 101350812
- Labeler code
- 10135
- Product ID
- 10135-812_31a907fc-2be0-1219-e063-6294a90ac00f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- ANDA207121
- Marketing category
- ANDA
- Marketing start
- 2025-03-01
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HYDROXYZINE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXYZINE DIHYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 76755771U3 |
| Rxcui | 995218, 995258, 995281 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-812-01 | HYDROXYZINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 10135-812-10 | HYDROXYZINE HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-812 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20250403_31a907e6-7fae-0682-e063-6294a90a24a5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 10135-812-01 | 10135081201 | 100 TABLET, FILM COATED in 1 BOTTLE (10135-812-01) | 2025-03-01 | No | No | Current |
| 10135-812-10 | 10135081210 | 1000 TABLET, FILM COATED in 1 BOTTLE (10135-812-10) | 2025-03-01 | No | No | Current |