Hydroxyzine Hydrochloride
- Product NDC
- 54838-502
- 11-digit product format
- 548380502
- Labeler code
- 54838
- Product ID
- 54838-502_823645dc-4e60-4279-97fa-ca0d1c1d7ad8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA201674
- Marketing category
- ANDA
- Marketing start
- 2013-08-21
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 10 mg/5mL
- 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 | 10 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 76755771U3 |
| Rxcui | 995241 |
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 |
|---|---|---|---|---|---|---|
| 54838-502-80 | Hydroxyzine Hydrochloride | 473 mL in 1 BOTTLE, PLASTIC | SOLUTION | 473 | 21 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54838-502-80 | ML - Milliliter | 54838-502 | 7421b4e0-021b-4a90-b40e-38db6c184823 | 1 | 2014-04-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Hydroxyzine Hydrochloride | ACTIVE INGREDIENT | 76755771U3 | HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [SILARX PHARMACEUTICALS, INC] | 7 | |
| Hydroxyzine | ACTIVE MOIETY | 30S50YM8OG | HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [SILARX PHARMACEUTICALS, INC] | 7 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [SILARX PHARMACEUTICALS, INC] | 7 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [SILARX PHARMACEUTICALS, INC] | 7 | |
| sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [SILARX PHARMACEUTICALS, INC] | 7 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [SILARX PHARMACEUTICALS, INC] | 7 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) SOLUTION [SILARX PHARMACEUTICALS, INC] | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 995241 | hydrOXYzine HCl 10 MG in 5 mL Oral Solution | PSN | a4fb61ae-aad6-4bd6-83fc-8b227f175df9 | 21 |
| 995241 | hydroxyzine hydrochloride 2 MG/ML Oral Solution | SCD | a4fb61ae-aad6-4bd6-83fc-8b227f175df9 | 21 |
| 995241 | hydroxyzine hydrochloride 10 MG per 5 ML Oral Solution | SY | a4fb61ae-aad6-4bd6-83fc-8b227f175df9 | 21 |
| 995241 | hydrOXYzine HCl 10 MG in 5 mL Oral Solution | PSN | a2fbc502-6ca3-4304-9069-b7249c9d9489 | 5 |
| 995241 | hydroxyzine hydrochloride 2 MG/ML Oral Solution | SCD | a2fbc502-6ca3-4304-9069-b7249c9d9489 | 5 |
| 995241 | hydroxyzine hydrochloride 10 MG per 5 ML Oral Solution | SY | a2fbc502-6ca3-4304-9069-b7249c9d9489 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 54838-502-80 | 54838050280 | 473 mL in 1 BOTTLE, PLASTIC (54838-502-80) | 473 ml | 2013-08-21 | 0000-00-00 | No | No | Current |