FDA.reportPublic FDA data

acyclovir

Product NDC
82804-245
11-digit product format
828040245
Labeler code
82804
Product ID
82804-245_d3dc05d3-5ea8-4d12-8bc8-31ea6ba9c909
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204313
Marketing category
ANDA
Marketing start
2019-08-23
Substance
ACYCLOVIR
Active strength
200 mg/1
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
acyclovir
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197310

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
82804-245-30acyclovir30 in 1 BOTTLECAPSULE302
82804-245-90acyclovir90 in 1 BOTTLECAPSULE902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNd4729677-164b-41b8-bbc4-4e47346b0f722
197310acyclovir 200 MG Oral CapsuleSCDd4729677-164b-41b8-bbc4-4e47346b0f722
197310acycycloguanosine 200 MG Oral CapsuleSYd4729677-164b-41b8-bbc4-4e47346b0f722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-245-308280402453030 CAPSULE in 1 BOTTLE (82804-245-30) 30 capsule2026-05-13NoNoCurrent
82804-245-908280402459090 CAPSULE in 1 BOTTLE (82804-245-90) 90 capsule2025-09-24NoNoCurrent