FDA.reportPublic FDA data

Fosamprenavir Calcium

Product NDC
0378-3520
11-digit product format
003783520
Labeler code
0378
Product ID
0378-3520_88dccf91-6e62-4f5f-849d-1ffa8bf8df9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fosamprenavir calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA204060
Marketing category
ANDA
Marketing start
2017-09-18
Substance
FOSAMPRENAVIR CALCIUM
Active strength
700 mg/1
Pharmacologic classes
Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], P-Glycoprotein Inducers [MoA], Protease Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fosamprenavir Calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSAMPRENAVIR CALCIUM700 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiID1GU2627N
Rxcui402109

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30518cdc-4e65-0105-bf49-967999bc76dbProduct name320200506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-3520-91Fosamprenavir Calcium60 in 1 BOTTLE, PLASTICTABLET, FILM COATED606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3520-91EA - Each0378-352029da0573-92d0-4230-9598-42df22357ebc12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-3520FOSAMPRENAVIR CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 1 package rows20231030_3a1424d8-844c-4e24-9ebd-b2c2b61b61a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402109fosamprenavir calcium 700 MG Oral TabletPSN3a1424d8-844c-4e24-9ebd-b2c2b61b61a36
402109fosamprenavir 700 MG Oral TabletSCD3a1424d8-844c-4e24-9ebd-b2c2b61b61a36
402109fosamprenavir (as fosamprenavir calcium) 700 MG (amprenavir 600 MG) Oral TabletSY3a1424d8-844c-4e24-9ebd-b2c2b61b61a36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-3520-910037835209160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3520-91) 2017-09-180000-00-00NoNoCurrent