Prescription drug · NDA
Plaquenil (Hydroxychloroquine sulfate) NDC 59212-562
Hydroxychloroquine sulfate 200 mg/1 · Tablet · Oral · Advanz Pharma (US) Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59212-562-10 | 5921205621059212056210 | 100 TABLET in 1 BOTTLE (59212-562-10)Marketed from Jun 28, 2013 | |
| 59212-562-11 | 5921205621159212056211 | 100 TABLET in 1 BOTTLE (59212-562-11)Marketed from Aug 10, 2020 | |
| 59212-562-60 | 5921205626059212056260 | 60 TABLET in 1 BOTTLE (59212-562-60)Marketed from Jan 5, 2019 |
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)
- Plaquenil
- Generic name (nonproprietary)
- hydroxychloroquine sulfate
- Active ingredients
- Hydroxychloroquine sulfate — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advanz Pharma (US) Corp.NDC labeler code 59212
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 009768
- Marketing start
- Listing expires
- Identifiers
- Product ID 59212-562_1138fd4e-dfba-4c96-a5ec-60f8bc1ba746SPL ID 1138fd4e-dfba-4c96-a5ec-60f8bc1ba746SPL set ID 34496b43-05a2-45fb-a769-52b12e099341RxCUI 979092, 979094UNII 8Q2869CNVHUPC 0359212562104
- 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
N459212056210followed by a unit qualifier and the quantityPackage 59212-0562-10. 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)
PLAQUENIL is 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): PLAQUENIL is not recommended for the: • Treatment of complicated malaria. • Treatment of chloroquine or hydroxychloroquine-resista…
Excerpt only. Read the full label for complete information.
About NDC 59212-562
- What is NDC 59212-562?
- 59212-562 is the product NDC for Plaquenil (hydroxychloroquine sulfate), Hydroxychloroquine sulfate 200 mg/1 tablet, listed with the FDA by Advanz Pharma (US) Corp.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Plaquenil (Hydroxychloroquine Sulfate).
- What is the active ingredient?
- Hydroxychloroquine sulfate.
- Who is the labeler?
- Advanz Pharma (US) Corp., NDC labeler code 59212. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Plaquenil?
- 2 other product NDCs are listed under this name. See all Plaquenil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Plaquenil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Plaquenilhydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Proficient Rx LP | 71205-448 | 71205-0448-12 |
| Plaquenilhydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-473 | 71610-0473-0471610-0473-3071610-0473-53+2 more |
Other NDCs under NDA 009768
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 |
|---|---|---|---|---|
| Plaquenilhydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Proficient Rx LP | 71205-448 |
| Plaquenilhydroxychloroquine sulfate | Hydroxychloroquine sulfate 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-473 |