Prescription drug · ANDA
hydroxyzine pamoate NDC 70518-4463
Hydroxyzine pamoate 50 mg/1 · Capsule · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)70518-4463Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-4463Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4463-0 | 7051844630070518446300 | 21 CAPSULE in 1 BLISTER PACK (70518-4463-0)Marketed from Aug 30, 2025 | |
| 70518-4463-1 | 7051844630170518446301 | 30 CAPSULE in 1 BLISTER PACK (70518-4463-1)Marketed from Sep 11, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- hydroxyzine pamoate
- Generic name (nonproprietary)
- hydroxyzine pamoate
- Active ingredients
- Hydroxyzine pamoate — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201507
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70518-4463_5b37f933-51f9-e3d2-e063-6394a90abf00SPL ID 5b37f933-51f9-e3d2-e063-6394a90abf00
- Pharmacologic class
- Antihistamine
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470518446300followed by a unit qualifier and the quantityPackage 70518-4463-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70518-4463
- What is NDC 70518-4463?
- 70518-4463 is the product NDC for hydroxyzine pamoate, Hydroxyzine pamoate 50 mg/1 capsule, listed with the FDA by REMEDYREPACK INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- hydroxyzine pamoate.
- What is the active ingredient?
- Hydroxyzine pamoate.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for hydroxyzine pamoate?
- 81 other product NDCs are listed under this name. See all hydroxyzine pamoate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other hydroxyzine pamoate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-087 | 87441-0087-01 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-040 | 87441-0040-01 |
| Hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-041 | 87441-0041-01 |
| Hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-042 | 87441-0042-01 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Coupler LLC | 67046-0281 | 67046-0281-03 |
| Hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Coupler LLC | 67046-0831 | 67046-0831-03 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Coupler LLC | 67046-2086 | 67046-2086-03 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1054 | 72162-1054-03 |
| hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8789 | 68788-8789-03 |
| hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-046 | 82868-0046-30 |
Other NDCs under ANDA 201507
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Coupler LLC | 67046-2086 |
| hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3583 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-001 |
| hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-002 |
| hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8789 |
| hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1265 |
| hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 14539-675 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 14539-674 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1325 |
| Hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-817 |
| Hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-816 |
| Hydroxyzine Pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Direct_Rx | 72189-009 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-773 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7065 |
| hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7540 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-725 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Proficient Rx LP | 71205-433 |
| hydroxyzine pamoate | Hydroxyzine pamoate 50 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-046 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-7767 |
| hydroxyzine pamoate | Hydroxyzine pamoate 25 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-4385 |
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