Hydroxyzine Hydrochloride
- Product NDC
- 0121-4822
- 11-digit product format
- 001214822
- Labeler code
- 0121
- Product ID
- 0121-4822_f86276e9-0aff-4be7-895d-437a11fd12ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Pharmaceutical Associates, Inc.
- Application
- ANDA087294
- Marketing category
- ANDA
- Marketing start
- 2015-01-01
- Marketing end
- 0000-00-00
- Substance
- HYDROXYZINE HYDROCHLORIDE
- Active strength
- 10 mg/5mL
- Pharmacologic classes
- Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0121-4822-12 | 2024-05-14 | C162847 | 48780-1 | 9d75b9d0-dde3-f424-e053-dadaa90a57ce | 85e3c789-a740-4a09-a810-9808c3d0f7d9 |
| 0121-4822-25 | 2024-05-14 | C162847 | 48780-1 | 9d75b9d0-dde3-f424-e053-dadaa90a57ce | 85e3c789-a740-4a09-a810-9808c3d0f7d9 |
| 0121-4822-12 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dde3-f424-e053-dadaa90a57ce | 85e3c789-a740-4a09-a810-9808c3d0f7d9 |
| 0121-4822-25 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dde3-f424-e053-dadaa90a57ce | 85e3c789-a740-4a09-a810-9808c3d0f7d9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-4822-25 | ML - Milliliter | 0121-4822 | fbbe98ff-ab0a-4875-8aea-5b4ff9f1eebe | 1 | 2015-04-03 |