Hydroxyzine Pamoate
- Product NDC
- 0115-1670
- 11-digit product format
- 001151670
- Labeler code
- 0115
- Product ID
- 0115-1670_c161bae2-8df7-45df-a8dc-d578d8d4379e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Pamoate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA040156
- Marketing category
- ANDA
- Marketing start
- 1996-07-15
- Marketing end
- 0000-00-00
- Substance
- HYDROXYZINE PAMOATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0115-1670-01 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-e48b-f424-e053-dadaa90a57ce | HydrOXYzine Pamoate Capsules USP Rx only |
| 0115-1670-02 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-e48b-f424-e053-dadaa90a57ce | HydrOXYzine Pamoate Capsules USP Rx only |
| 0115-1670-01 | 2020-12-29 | C162847 | 48780-1 | 9d75b9d0-e48b-f424-e053-dadaa90a57ce | HydrOXYzine Pamoate Capsules USP Rx only |
| 0115-1670-02 | 2020-12-29 | C162847 | 48780-1 | 9d75b9d0-e48b-f424-e053-dadaa90a57ce | HydrOXYzine Pamoate Capsules USP Rx only |
| 0115-1670-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e48b-f424-e053-dadaa90a57ce | HydrOXYzine Pamoate Capsules USP Rx only |
| 0115-1670-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e48b-f424-e053-dadaa90a57ce | HydrOXYzine Pamoate Capsules USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0115-1670-01 | Hydroxyzine Pamoate | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | 5 | |
| 0115-1670-02 | Hydroxyzine Pamoate | 500 in 1 BOTTLE, PLASTIC | CAPSULE | 500 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0115-1670-01 | EA - Each | 0115-1670 | 03c4f25e-1871-4f52-bddc-b1ba7a66562b | 1 | 2017-03-06 |
| 0115-1670-02 | EA - Each | 0115-1670 | be4d54ad-5b49-495e-b29d-a14733d0806a | 1 | 2017-04-05 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 995253 | hydrOXYzine pamoate 25 MG Oral Capsule | PSN | 53d3540a-667d-474e-9994-aed08b3b1604 | 5 |
| 995278 | hydrOXYzine pamoate 50 MG Oral Capsule | PSN | 53d3540a-667d-474e-9994-aed08b3b1604 | 5 |
| 995253 | hydroxyzine pamoate 25 MG Oral Capsule | SCD | 53d3540a-667d-474e-9994-aed08b3b1604 | 5 |
| 995278 | hydroxyzine pamoate 50 MG Oral Capsule | SCD | 53d3540a-667d-474e-9994-aed08b3b1604 | 5 |
| 995278 | hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule | SY | 53d3540a-667d-474e-9994-aed08b3b1604 | 5 |
| 995253 | hydrOXYzine pamoate 25 MG Oral Capsule | PSN | 04657694-e8a8-4e52-a179-cfe752819760 | 4 |
| 995253 | hydroxyzine pamoate 25 MG Oral Capsule | SCD | 04657694-e8a8-4e52-a179-cfe752819760 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0115-1670-01 | 00115167001 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0115-1670-01) | 100 capsule | 1996-07-15 | 0000-00-00 | No | No | Current |
| 0115-1670-02 | 00115167002 | 500 CAPSULE in 1 BOTTLE, PLASTIC (0115-1670-02) | 500 capsule | 1996-07-15 | 0000-00-00 | No | No | Current |