Hydroxyzine Hydrochloride
- Product NDC
- 10702-011
- 11-digit product format
- 107020011
- Labeler code
- 10702
- Product ID
- 10702-011_eff46bea-a884-5878-e053-2a95a90ae664
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- KVK-Tech, Inc.
- Application
- ANDA040786
- Marketing category
- ANDA
- Marketing start
- 2012-07-24
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 25 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 |
|---|---|
| HYDROXYZINE DIHYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 76755771U3 |
| Rxcui | 995218, 995258, 995281 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 57311cfb-679a-da1a-b70c-8757f7fc431a | Product name | 4 | 20250516 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| aa1826f4-97c1-4705-bdf0-3bc7d234e618 | Product name | 2 | 20190618 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 75cb12ee-8eb2-4f1a-a332-5743a5d0da41 | Product name | 1 | 20151110 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 3ca5f78b-43dc-30fe-8014-55b922af52b3 | Product name | 1 | 20140508 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10702-011-01 | Hydroxyzine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 12 | |
| 10702-011-10 | Hydroxyzine Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 12 | |
| 10702-011-50 | Hydroxyzine Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | 24cb9c83-a7e4-4bae-997c-c3a87426f78c | 23 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | 24cb9c83-a7e4-4bae-997c-c3a87426f78c | 23 |
| 995218 | hydrOXYzine HCl 10 MG Oral Tablet | PSN | 1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1 | 22 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | 1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1 | 22 |
| 995281 | hydrOXYzine HCl 50 MG Oral Tablet | PSN | 1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1 | 22 |
| 995218 | hydroxyzine hydrochloride 10 MG Oral Tablet | SCD | 1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1 | 22 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | 1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1 | 22 |
| 995281 | hydroxyzine hydrochloride 50 MG Oral Tablet | SCD | 1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1 | 22 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | cc6a12ed-411b-4b0c-8108-58ef7db8da55 | 16 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | cc6a12ed-411b-4b0c-8108-58ef7db8da55 | 16 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | aa9523e0-c95d-4213-b213-96170d855536 | 14 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | aa9523e0-c95d-4213-b213-96170d855536 | 14 |
| 995218 | hydrOXYzine HCl 10 MG Oral Tablet | PSN | adc4cb73-77c6-48ff-aaf2-b3568d53de1f | 12 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | adc4cb73-77c6-48ff-aaf2-b3568d53de1f | 12 |
| 995281 | hydrOXYzine HCl 50 MG Oral Tablet | PSN | adc4cb73-77c6-48ff-aaf2-b3568d53de1f | 12 |
| 995218 | hydroxyzine hydrochloride 10 MG Oral Tablet | SCD | adc4cb73-77c6-48ff-aaf2-b3568d53de1f | 12 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | adc4cb73-77c6-48ff-aaf2-b3568d53de1f | 12 |
| 995281 | hydroxyzine hydrochloride 50 MG Oral Tablet | SCD | adc4cb73-77c6-48ff-aaf2-b3568d53de1f | 12 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | 78eaf4fd-26c7-83bc-e053-2a91aa0a94d3 | 2 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | 888e3d6c-a2e4-11e3-e053-2a95a90af279 | 2 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | 78eaf4fd-26c7-83bc-e053-2a91aa0a94d3 | 2 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | 888e3d6c-a2e4-11e3-e053-2a95a90af279 | 2 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | 308252c8-08ef-4864-846b-fbcae823141f | 1 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | beefb4ba-ee88-4923-96b0-72050466847b | 1 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | 3f5be725-8ade-4889-b6b1-7d45f5458546 | 1 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | beefb4ba-ee88-4923-96b0-72050466847b | 1 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | 308252c8-08ef-4864-846b-fbcae823141f | 1 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | 3f5be725-8ade-4889-b6b1-7d45f5458546 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10702-011-01 | 10702001101 | 100 TABLET, FILM COATED in 1 BOTTLE (10702-011-01) | 2012-07-24 | 0000-00-00 | No | No | Current |
| 10702-011-10 | 10702001110 | 1000 TABLET, FILM COATED in 1 BOTTLE (10702-011-10) | 2012-07-24 | 0000-00-00 | No | No | Current |
| 10702-011-50 | 10702001150 | 500 TABLET, FILM COATED in 1 BOTTLE (10702-011-50) | 2012-07-24 | 0000-00-00 | No | No | Current |