HYDROXYZINE HYDROCHLORIDE
- Product NDC
- 16571-114
- 11-digit product format
- 165710114
- Labeler code
- 16571
- Product ID
- 16571-114_20aba551-c0c0-4ea1-8200-ad81956ff294
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydroxyzine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA217652
- Marketing category
- ANDA
- Marketing start
- 2023-08-22
- 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 |
| aa1826f4-97c1-4705-bdf0-3bc7d234e618 | Product name | 2 | 20190618 |
| 75cb12ee-8eb2-4f1a-a332-5743a5d0da41 | Product name | 1 | 20151110 |
| 3ca5f78b-43dc-30fe-8014-55b922af52b3 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16571-114-01 | HYDROXYZINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 3 | |
| 16571-114-10 | HYDROXYZINE HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 3 | |
| 16571-114-50 | HYDROXYZINE HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | 8f41912e-12ce-4174-a0fb-cfb4888d8d58 | 6 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | 8f41912e-12ce-4174-a0fb-cfb4888d8d58 | 6 |
| 995218 | hydrOXYzine HCl 10 MG Oral Tablet | PSN | 6a1a48ac-8ad5-4363-b298-d9825ae2a448 | 3 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | a8525244-2acb-4e3e-9769-bbc90549a188 | 3 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | 87b79b7c-0398-47dc-858d-62e44a1b02f4 | 3 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | 69a58bc6-c8a4-48ad-ac77-90fac42e0398 | 3 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | 6a1a48ac-8ad5-4363-b298-d9825ae2a448 | 3 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | 7edd582c-039c-4bdc-bf8a-61eac8a5a9a0 | 3 |
| 995281 | hydrOXYzine HCl 50 MG Oral Tablet | PSN | 6a1a48ac-8ad5-4363-b298-d9825ae2a448 | 3 |
| 995218 | hydroxyzine hydrochloride 10 MG Oral Tablet | SCD | 6a1a48ac-8ad5-4363-b298-d9825ae2a448 | 3 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | a8525244-2acb-4e3e-9769-bbc90549a188 | 3 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | 69a58bc6-c8a4-48ad-ac77-90fac42e0398 | 3 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | 87b79b7c-0398-47dc-858d-62e44a1b02f4 | 3 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | 6a1a48ac-8ad5-4363-b298-d9825ae2a448 | 3 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | 7edd582c-039c-4bdc-bf8a-61eac8a5a9a0 | 3 |
| 995281 | hydroxyzine hydrochloride 50 MG Oral Tablet | SCD | 6a1a48ac-8ad5-4363-b298-d9825ae2a448 | 3 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | a9a133e6-efce-4bdb-9335-49c74e57fafe | 1 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | 519e54e0-a613-e7b3-e063-6294a90a4452 | 1 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | afa74394-c079-4ad3-b555-270fe0de3d62 | 1 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | 4aa896b1-4fd5-513e-e063-6294a90ab950 | 1 |
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | 30b6f7b3-b620-961a-e063-6394a90a487b | 1 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | afa74394-c079-4ad3-b555-270fe0de3d62 | 1 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | a9a133e6-efce-4bdb-9335-49c74e57fafe | 1 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | 519e54e0-a613-e7b3-e063-6294a90a4452 | 1 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | 4aa896b1-4fd5-513e-e063-6294a90ab950 | 1 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | 30b6f7b3-b620-961a-e063-6394a90a487b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 16571-114-01 | 16571011401 | 100 TABLET, FILM COATED in 1 BOTTLE (16571-114-01) | 2023-08-22 | No | No | Current |
| 16571-114-10 | 16571011410 | 1000 TABLET, FILM COATED in 1 BOTTLE (16571-114-10) | 2023-08-22 | No | No | Current |
| 16571-114-50 | 16571011450 | 500 TABLET, FILM COATED in 1 BOTTLE (16571-114-50) | 2023-08-22 | No | No | Current |