FDA.reportPublic FDA data

Acyclovir

Product NDC
82804-005
11-digit product format
828040005
Labeler code
82804
Product ID
82804-005_2ff9056b-ed65-4a2b-abb1-793b1fe9bf4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA210401
Marketing category
ANDA
Marketing start
2023-06-20
Substance
ACYCLOVIR
Active strength
400 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197311

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
82804-005-06Acyclovir6 in 1 BOTTLETABLET62
82804-005-15Acyclovir15 in 1 BOTTLETABLET152
82804-005-20Acyclovir20 in 1 BOTTLETABLET202
82804-005-21Acyclovir21 in 1 BOTTLETABLET212
82804-005-30Acyclovir30 in 1 BOTTLETABLET302
82804-005-35Acyclovir35 in 1 BOTTLETABLET352
82804-005-60Acyclovir60 in 1 BOTTLETABLET602
82804-005-90Acyclovir90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-005-21EA - Each82804-005214b841f-38a7-4d5f-b068-e2958b11802d12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-005ACYCLOVIR TABLET [PROFICIENT RX LP]2Current NDC, 8 package rows20240112_97ed8713-4b3e-48a9-92c0-0a98ecf0485c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN97ed8713-4b3e-48a9-92c0-0a98ecf0485c2
197311acyclovir 400 MG Oral TabletSCD97ed8713-4b3e-48a9-92c0-0a98ecf0485c2
197311acycycloguanosine 400 MG Oral TabletSY97ed8713-4b3e-48a9-92c0-0a98ecf0485c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-005-06828040005066 TABLET in 1 BOTTLE (82804-005-06) 6 tablet2024-01-09NoNoCurrent
82804-005-158280400051515 TABLET in 1 BOTTLE (82804-005-15) 15 tablet2024-01-09NoNoCurrent
82804-005-208280400052020 TABLET in 1 BOTTLE (82804-005-20) 20 tablet2024-01-09NoNoCurrent
82804-005-218280400052121 TABLET in 1 BOTTLE (82804-005-21) 21 tablet2024-01-09NoNoCurrent
82804-005-308280400053030 TABLET in 1 BOTTLE (82804-005-30) 30 tablet2023-08-31NoNoCurrent
82804-005-358280400053535 TABLET in 1 BOTTLE (82804-005-35) 35 tablet2024-01-09NoNoCurrent
82804-005-608280400056060 TABLET in 1 BOTTLE (82804-005-60) 60 tablet2023-08-31NoNoCurrent
82804-005-908280400059090 TABLET in 1 BOTTLE (82804-005-90) 90 tablet2023-08-31NoNoCurrent