What is NDC 63304-583?

63304-583 is the product NDC for Fosamprenavir Calcium, Fosamprenavir calcium 700 mg/1 tablet, coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fosamprenavir Calcium?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fosamprenavir Calcium NDC 63304-583 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63304-583Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63304-0583Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
63304-583-01	63304058301	100 TABLET, COATED in 1 BOTTLE (63304-583-01)Marketed from Nov 28, 2019
63304-583-30	63304058330	30 TABLET, COATED in 1 BOTTLE (63304-583-30)Marketed from Nov 28, 2019
63304-583-60	63304058360	60 TABLET, COATED in 1 BOTTLE (63304-583-60)Marketed from Nov 28, 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): Fosamprenavir Calcium
Generic name (nonproprietary): fosamprenavir calcium
Active ingredients: Fosamprenavir calcium — 700 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 63304
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204024
Marketing start: Nov 28, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 3A4 Inducers (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)HIV Protease Inhibitors (Mechanism)P-Glycoprotein Inducers (Mechanism)
Identifiers: Product ID 63304-583_55b3e01f-ee36-c52e-e063-6294a90ad61cSPL ID 55b3e01f-ee36-c52e-e063-6294a90ad61cSPL set ID 5cd1eead-9fc1-426c-bee8-214ffa7d9dc1RxCUI 402109UNII ID1GU2627N
Pharmacologic class: Protease Inhibitor

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

N463304058301 followed by a unit qualifier and the quantity

Package 63304-0583-01. 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 Jun 30, 2026.

Indications (excerpt from the label)

Fosamprenavir calcium tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. The following points should be considered when initiating therapy with fosamprenavir calcium tablets plus ritonavir in protease inhibitor-experienced patients: The protease inhibitor-experienced patient trial was not large enough to reach a definitive conclusion that fosamprenavir calcium tablets plus ritonavir and lopinavir plus ritonavir are clinically equivalent [see Clinical Studies (14.2)] . Once-daily administration of fosamprenavir calcium tablets plus ritonavir is not recommended for adult protease inhibitor-experienced patie…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63304-583

What is NDC 63304-583?: 63304-583 is the product NDC for Fosamprenavir Calcium, Fosamprenavir calcium 700 mg/1 tablet, coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fosamprenavir Calcium.
What is the active ingredient?: Fosamprenavir calcium.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fosamprenavir Calcium?: 1 other product NDC are listed under this name. See all Fosamprenavir Calcium NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fosamprenavir Calcium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fosamprenavir Calcium	Fosamprenavir calcium 700 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-3520	00378-3520-91