Prescription drug · ANDA
Hydroxychloroquine Sulfate NDC 82619-131
Hydroxychloroquine sulfate 200 mg/1 · Tablet · Oral · Creekwood Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82619-131-01 | 8261901310182619013101 | 100 TABLET in 1 BOTTLE (82619-131-01)Marketed from May 8, 2025 | |
| 82619-131-02 | 8261901310282619013102 | 500 TABLET in 1 BOTTLE (82619-131-02)Marketed from May 8, 2025 | |
| 82619-131-03 | 8261901310382619013103 | 1000 TABLET in 1 BOTTLE (82619-131-03)Marketed from May 8, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Hydroxychloroquine Sulfate
- Generic name (nonproprietary)
- hydroxychloroquine sulfate
- Active ingredients
- Hydroxychloroquine sulfate — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Creekwood Pharmaceuticals LLCNDC labeler code 82619
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040150
- Marketing start
- Listing expires
- Identifiers
- Product ID 82619-131_40b93dff-c062-433c-e063-6294a90a6b67SPL ID 40b93dff-c062-433c-e063-6294a90a6b67SPL set ID 04139607-f7c0-4fe1-a210-ffa5af347d56RxCUI 979092UNII 8Q2869CNVHUPC 0382619131017, 0382619131024, 0382619131031
- Pharmacologic class
- Antimalarial; Antirheumatic Agent
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
N482619013101followed by a unit qualifier and the quantityPackage 82619-0131-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Hydroxychloroquine sulfate tablets are an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. ( 1.1 ) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. ( 1.1 ) Treatment of rheumatoid arthritis in adults. ( 1.2 ) Treatment of systemic lupus erythematosus in adults. ( 1.3 ) Treatment of chronic discoid lupus erythematosus in adults. ( 1.4 ) Limitations of Use ( 1.1 ): Hydroxychloroquine sulfate tablets are not recommended for the: Treatment of complicated malaria. Treat…
Excerpt only. Read the full label for complete information.
About NDC 82619-131
- What is NDC 82619-131?
- 82619-131 is the product NDC for Hydroxychloroquine Sulfate, Hydroxychloroquine sulfate 200 mg/1 tablet, listed with the FDA by Creekwood Pharmaceuticals LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydroxychloroquine Sulfate.
- What is the active ingredient?
- Hydroxychloroquine sulfate.
- Who is the labeler?
- Creekwood Pharmaceuticals LLC, NDC labeler code 82619. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydroxychloroquine Sulfate?
- 51 other product NDCs are listed under this name. See all Hydroxychloroquine Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydroxychloroquine Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-040 | 53401-0040-5353401-0040-6053401-0040-70+1 more |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2813 | 71335-2813-01 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2814 | 71335-2814-01 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3113 | 71335-3113-0171335-3113-0271335-3113-03+6 more |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3142 | 71335-3142-0171335-3142-0271335-3142-03+6 more |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2467 | 72162-2467-0172162-2467-05 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-889 | 59651-0889-0159651-0889-05 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1523 | 67046-1523-03 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3079 | 71335-3079-0171335-3079-0271335-3079-03+6 more |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | Tablet, Film coatedOral | Ipca Laboratories Limited | 83980-001 | 83980-0001-0183980-0001-0583980-0001-10+1 more |
Other NDCs under ANDA 040150
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 |
|---|---|---|---|---|
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-040 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2813 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2814 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3113 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3142 |
| Hydroxychloroquine Sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2467 |