Hydroxyzine Hydrochloride
- Product NDC
- 71205-083
- 11-digit product format
- 712050083
- Labeler code
- 71205
- Product ID
- 71205-083_6eebea17-bc98-49a2-854c-35267194f4c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA088619
- Marketing category
- ANDA
- Marketing start
- 2012-10-22
- 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 | 995281 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71205-083-15 | Hydroxyzine Hydrochloride | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 5 |
| 71205-083-20 | Hydroxyzine Hydrochloride | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 5 |
| 71205-083-30 | Hydroxyzine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 71205-083-60 | Hydroxyzine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 5 |
| 71205-083-90 | Hydroxyzine Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-083 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 5 package rows | 20221104_642ff329-c551-44f0-b340-49313db868c5.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 |
|---|
| 71205-083-15 | 71205008315 | 15 TABLET, FILM COATED in 1 BOTTLE (71205-083-15) | 2018-08-01 | 0000-00-00 | No | No | Current |
| 71205-083-20 | 71205008320 | 20 TABLET, FILM COATED in 1 BOTTLE (71205-083-20) | 2018-08-01 | 0000-00-00 | No | No | Current |
| 71205-083-30 | 71205008330 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-083-30) | 2018-08-01 | 0000-00-00 | No | No | Current |
| 71205-083-60 | 71205008360 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-083-60) | 2018-08-01 | 0000-00-00 | No | No | Current |
| 71205-083-90 | 71205008390 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-083-90) | 2018-08-01 | 0000-00-00 | No | No | Current |