FDA.reportPublic FDA data

acyclovir

Product NDC
72578-002
11-digit product format
725780002
Labeler code
72578
Product ID
72578-002_b797bf2f-d83c-413a-90bf-63c3a0eabf89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
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
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
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
72578-002-01acyclovir100 in 1 BOTTLECAPSULE1005
72578-002-05acyclovir500 in 1 BOTTLECAPSULE5005
72578-002-06acyclovir30 in 1 BOTTLECAPSULE305
72578-002-10acyclovir1000 in 1 BOTTLECAPSULE10005
72578-002-16acyclovir90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-002-01EA - Each72578-002f08917d2-e772-4702-bf5c-32379ec5b07112021-02-05
72578-002-05EA - Each72578-00214e14538-73b3-4116-87d9-8fe3743d6ba412021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-002ACYCLOVIR CAPSULE [VIONA PHARMACEUTICALS INC]4Current NDC, Legacy NDC, 5 package rows20231101_e580b7e9-9060-43f5-9b58-33998078d7e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNc818e86c-a4d0-48cd-a888-fa1ee9e2aa19101
197310acyclovir 200 MG Oral CapsuleSCDc818e86c-a4d0-48cd-a888-fa1ee9e2aa19101
197310acycycloguanosine 200 MG Oral CapsuleSYc818e86c-a4d0-48cd-a888-fa1ee9e2aa19101
197310acyclovir 200 MG Oral CapsulePSN0990b625-5dfe-4810-b5b4-ac5948599e797
197310acyclovir 200 MG Oral CapsuleSCD0990b625-5dfe-4810-b5b4-ac5948599e797
197310acycycloguanosine 200 MG Oral CapsuleSY0990b625-5dfe-4810-b5b4-ac5948599e797
197310acyclovir 200 MG Oral CapsulePSNe580b7e9-9060-43f5-9b58-33998078d7e45
197310acyclovir 200 MG Oral CapsuleSCDe580b7e9-9060-43f5-9b58-33998078d7e45
197310acycycloguanosine 200 MG Oral CapsuleSYe580b7e9-9060-43f5-9b58-33998078d7e45
197310acyclovir 200 MG Oral CapsulePSNff9776b3-a248-e1ea-e053-6294a90aeb7b3
197310acyclovir 200 MG Oral CapsulePSNcacaeb2a-6d3b-cf3e-e053-2a95a90a6ce43
197310acyclovir 200 MG Oral CapsulePSNa0ed999f-7366-42c3-a6f5-3c239215a99c3
197310acyclovir 200 MG Oral CapsuleSCDa0ed999f-7366-42c3-a6f5-3c239215a99c3
197310acyclovir 200 MG Oral CapsuleSCDcacaeb2a-6d3b-cf3e-e053-2a95a90a6ce43
197310acyclovir 200 MG Oral CapsuleSCDff9776b3-a248-e1ea-e053-6294a90aeb7b3
197310acycycloguanosine 200 MG Oral CapsuleSYa0ed999f-7366-42c3-a6f5-3c239215a99c3
197310acycycloguanosine 200 MG Oral CapsuleSYcacaeb2a-6d3b-cf3e-e053-2a95a90a6ce43
197310acycycloguanosine 200 MG Oral CapsuleSYff9776b3-a248-e1ea-e053-6294a90aeb7b3
197310acyclovir 200 MG Oral CapsulePSNfcc7fd8f-b361-463e-90ae-59397e48866e2
197310acyclovir 200 MG Oral CapsulePSNd4729677-164b-41b8-bbc4-4e47346b0f722
197310acyclovir 200 MG Oral CapsulePSNf4c224c8-c28c-254c-e053-2a95a90a9cda2
197310acyclovir 200 MG Oral CapsuleSCDd4729677-164b-41b8-bbc4-4e47346b0f722
197310acyclovir 200 MG Oral CapsuleSCDfcc7fd8f-b361-463e-90ae-59397e48866e2
197310acyclovir 200 MG Oral CapsuleSCDf4c224c8-c28c-254c-e053-2a95a90a9cda2
197310acycycloguanosine 200 MG Oral CapsuleSYf4c224c8-c28c-254c-e053-2a95a90a9cda2
197310acycycloguanosine 200 MG Oral CapsuleSYd4729677-164b-41b8-bbc4-4e47346b0f722
197310acycycloguanosine 200 MG Oral CapsuleSYfcc7fd8f-b361-463e-90ae-59397e48866e2
197310acyclovir 200 MG Oral CapsulePSN266bb8b5-f762-e84d-e063-6394a90ae1b91
197310acyclovir 200 MG Oral CapsulePSN86c43bdf-c5bf-47cd-8dfd-8112638258781
197310acyclovir 200 MG Oral CapsuleSCD266bb8b5-f762-e84d-e063-6394a90ae1b91
197310acyclovir 200 MG Oral CapsuleSCD86c43bdf-c5bf-47cd-8dfd-8112638258781
197310acycycloguanosine 200 MG Oral CapsuleSY266bb8b5-f762-e84d-e063-6394a90ae1b91
197310acycycloguanosine 200 MG Oral CapsuleSY86c43bdf-c5bf-47cd-8dfd-8112638258781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-002-0172578000201100 CAPSULE in 1 BOTTLE (72578-002-01) 100 capsule2019-08-230000-00-00NoNoCurrent
72578-002-0572578000205500 CAPSULE in 1 BOTTLE (72578-002-05) 500 capsule2019-08-230000-00-00NoNoCurrent
72578-002-067257800020630 CAPSULE in 1 BOTTLE (72578-002-06) 30 capsule2019-08-230000-00-00NoNoCurrent
72578-002-10725780002101000 CAPSULE in 1 BOTTLE (72578-002-10) 1000 capsule2019-08-230000-00-00NoNoCurrent
72578-002-167257800021690 CAPSULE in 1 BOTTLE (72578-002-16) 90 capsule2019-08-230000-00-00NoNoCurrent