Hydroxyzine Hydrochloride
- Product NDC
- 71335-1121
- 11-digit product format
- 713351121
- Labeler code
- 71335
- Product ID
- 71335-1121_cd25e2c5-25ff-46ae-80ef-b01300cd959d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA040600
- Marketing category
- ANDA
- Marketing start
- 2015-03-31
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 76755771U3 |
| Rxcui | 995218, 995258 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1121-1 | Hydroxyzine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 71335-1121-2 | Hydroxyzine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 71335-1121-3 | Hydroxyzine Hydrochloride | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 3 |
| 71335-1121-4 | Hydroxyzine Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
| 71335-1121-5 | Hydroxyzine Hydrochloride | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 3 |
| 71335-1121-6 | Hydroxyzine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
| 71335-1121-7 | Hydroxyzine Hydrochloride | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 3 |
| 71335-1121-8 | Hydroxyzine Hydrochloride | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1121 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 3 | Current NDC, Legacy NDC, 8 package rows | 20240410_1c7d31fb-5e3c-456e-be6c-a3baafe60c37.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1121-1 | 71335112101 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1121-1) | 2019-03-07 | 0000-00-00 | No | No | Current |
| 71335-1121-2 | 71335112102 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1121-2) | 2019-03-07 | 0000-00-00 | No | No | Current |
| 71335-1121-3 | 71335112103 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1121-3) | 2019-03-07 | 0000-00-00 | No | No | Current |
| 71335-1121-4 | 71335112104 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1121-4) | 2024-04-02 | 0000-00-00 | No | No | Current |
| 71335-1121-5 | 71335112105 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1121-5) | 2019-03-07 | 0000-00-00 | No | No | Current |
| 71335-1121-6 | 71335112106 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1121-6) | 2019-03-07 | 0000-00-00 | No | No | Current |
| 71335-1121-7 | 71335112107 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1121-7) | 2019-03-07 | 0000-00-00 | No | No | Current |
| 71335-1121-8 | 71335112108 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-1121-8) | 2019-03-07 | 0000-00-00 | No | No | Current |