What is NDC 0378-3520?

0378-3520 is the product NDC for Fosamprenavir Calcium, Fosamprenavir calcium 700 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 0378-3520

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-3520Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-3520Add 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	Copy
0378-3520-91	0037835209100378352091	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3520-91)Marketed from Sep 18, 2017

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204060
Marketing start: Sep 18, 2017
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 0378-3520_88dccf91-6e62-4f5f-849d-1ffa8bf8df9dSPL ID 88dccf91-6e62-4f5f-849d-1ffa8bf8df9dSPL set ID 3a1424d8-844c-4e24-9ebd-b2c2b61b61a3RxCUI 402109UNII ID1GU2627NUPC 0303783520919
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

N400378352091 followed by a unit qualifier and the quantity

Package 00378-3520-91. 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 Sep 15, 2023.

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 plus ritonavir in protease inhibitor-experienced patients: • The protease inhibitor-experienced patient trial was not large enough to reach a definitive conclusion that fosamprenavir plus ritonavir and lopinavir plus ritonavir are clinically equivalent [see Clinical Studies (14.2) ] . • Once-daily administration of fosamprenavir plus ritonavir is not recommended for adult protease inhibitor-experienced patients or any pediatric patients [see Dosage a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-3520

What is NDC 0378-3520?: 0378-3520 is the product NDC for Fosamprenavir Calcium, Fosamprenavir calcium 700 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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, CoatedOral	Sun Pharmaceutical Industries, Inc.	63304-583	63304-0583-0163304-0583-3063304-0583-60