FDA.reportPublic FDA data

Acyclovir

Product NDC
71335-0280
11-digit product format
713350280
Labeler code
71335
Product ID
71335-0280_93e7b597-948f-49e9-a4f1-8c4fe9074758
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075090
Marketing category
ANDA
Marketing start
2021-05-27
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
71335-0280-0Acyclovir90 in 1 BOTTLECAPSULE9011
71335-0280-1Acyclovir30 in 1 BOTTLECAPSULE3011
71335-0280-2Acyclovir25 in 1 BOTTLECAPSULE2511
71335-0280-3Acyclovir35 in 1 BOTTLECAPSULE3511
71335-0280-4Acyclovir50 in 1 BOTTLECAPSULE5011
71335-0280-5Acyclovir100 in 1 BOTTLECAPSULE10011
71335-0280-6Acyclovir40 in 1 BOTTLECAPSULE4011
71335-0280-7Acyclovir60 in 1 BOTTLECAPSULE6011
71335-0280-8Acyclovir120 in 1 BOTTLECAPSULE12011
71335-0280-9Acyclovir20 in 1 BOTTLECAPSULE2011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0280-0EA - Each71335-0280c3b97365-ee91-4553-8175-0a4813b9c83c12018-01-12
71335-0280-1EA - Each71335-02807ba075fb-40e4-4e05-b52a-d73b8f480dea12018-01-12
71335-0280-2EA - Each71335-028098aa85cd-36b3-4946-b424-71de53c2e5e812018-01-12
71335-0280-3EA - Each71335-0280a5b2e4c7-9698-408c-b986-e51d038faae912018-01-12
71335-0280-4EA - Each71335-02808b9be087-a8ca-454a-935a-78fbb1bfe18112018-01-12
71335-0280-5EA - Each71335-028035143eb2-f8c3-4203-99d7-a2d9409e305b12018-01-12
71335-0280-6EA - Each71335-0280963f08bc-c75c-4636-b82f-ea92a0319a0b12018-01-12
71335-0280-7EA - Each71335-02804b0607fc-e5f5-4ff0-aaf6-ca7efe2f204b12018-01-12
71335-0280-8EA - Each71335-0280c59dfccf-745c-4379-9036-8676c65d5c0512018-01-12
71335-0280-9EA - Each71335-02800138a94e-40d7-46a6-a532-09ac8647055a12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0280ACYCLOVIR CAPSULE [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 10 package rows20250212_f87c2c1e-568f-49e1-979e-fce80086fe08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNf87c2c1e-568f-49e1-979e-fce80086fe0811
197310acyclovir 200 MG Oral CapsuleSCDf87c2c1e-568f-49e1-979e-fce80086fe0811
197310acycycloguanosine 200 MG Oral CapsuleSYf87c2c1e-568f-49e1-979e-fce80086fe0811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0280-07133502800090 CAPSULE in 1 BOTTLE (71335-0280-0) 90 capsule2021-07-210000-00-00NoNoCurrent
71335-0280-17133502800130 CAPSULE in 1 BOTTLE (71335-0280-1) 30 capsule2021-12-270000-00-00NoNoCurrent
71335-0280-27133502800225 CAPSULE in 1 BOTTLE (71335-0280-2) 25 capsule2021-12-270000-00-00NoNoCurrent
71335-0280-37133502800335 CAPSULE in 1 BOTTLE (71335-0280-3) 35 capsule2021-12-270000-00-00NoNoCurrent
71335-0280-47133502800450 CAPSULE in 1 BOTTLE (71335-0280-4) 50 capsule2021-12-270000-00-00NoNoCurrent
71335-0280-571335028005100 CAPSULE in 1 BOTTLE (71335-0280-5) 100 capsule2021-12-270000-00-00NoNoCurrent
71335-0280-67133502800640 CAPSULE in 1 BOTTLE (71335-0280-6) 40 capsule2021-12-270000-00-00NoNoCurrent
71335-0280-77133502800760 CAPSULE in 1 BOTTLE (71335-0280-7) 60 capsule2021-12-270000-00-00NoNoCurrent
71335-0280-871335028008120 CAPSULE in 1 BOTTLE (71335-0280-8) 120 capsule2021-10-210000-00-00NoNoCurrent
71335-0280-97133502800920 CAPSULE in 1 BOTTLE (71335-0280-9) 20 capsule2021-12-270000-00-00NoNoCurrent