FDA.reportPublic FDA data

Avaclyr

Product NDC
48102-028
11-digit product format
481020028
Labeler code
48102
Product ID
48102-028_8b20bece-92d7-4715-aad0-6eddba900c2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Fera Pharmaceuticals, LLC
Application
NDA202408
Marketing category
NDA
Marketing start
2026-01-31
Substance
ACYCLOVIR
Active strength
30 mg/g
Pharmacologic classes
DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Avaclyr
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui199413, 2734142

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33190c02-82e1-0a4d-d716-9ccd23588463Product name520250225
c367d1da-5a72-8966-6d11-1eb9a73ae758Product name320231115
5518bf13-db2f-2e9c-3679-e70ecf03752cProduct name920210614
27897900-0e40-497b-97e1-88057e68fe6cProduct name420200710
ca834e59-e669-229c-9288-0ccb76dc373eProduct name920200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28Product name120190702
fb15b394-3715-4c87-a447-421489aa8739Product name320170727
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48102-028-35Avaclyr3.5 g in 1 TUBEOINTMENT3.53
48102-028-35Avaclyr1 in 1 CARTONOINTMENT13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199413acyclovir 3 % Ophthalmic OintmentPSN3ce26231-bc40-48b0-85e5-2e7622f334d73
2734142Avaclyr 3 % Ophthalmic OintmentPSN3ce26231-bc40-48b0-85e5-2e7622f334d73
2734142acyclovir 0.03 MG/MG Ophthalmic Ointment [Avaclyr]SBD3ce26231-bc40-48b0-85e5-2e7622f334d73
199413acyclovir 0.03 MG/MG Ophthalmic OintmentSCD3ce26231-bc40-48b0-85e5-2e7622f334d73
199413acyclovir 3 % Ophthalmic OintmentSY3ce26231-bc40-48b0-85e5-2e7622f334d73
199413acycycloguanosine 0.03 MG/MG Ophthalmic OintmentSY3ce26231-bc40-48b0-85e5-2e7622f334d73
2734142acycycloguanosine 0.03 MG/MG Ophthalmic Ointment [Avaclyr]SY3ce26231-bc40-48b0-85e5-2e7622f334d73
2734142Avaclyr 0.03 MG/MG Ophthalmic OintmentSY3ce26231-bc40-48b0-85e5-2e7622f334d73
2734142Avaclyr 3 % Ophthalmic OintmentSY3ce26231-bc40-48b0-85e5-2e7622f334d73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48102-028-35481020028351 TUBE in 1 CARTON (48102-028-35) / 3.5 g in 1 TUBE1 tube2026-01-31NoNoCurrent