FDA.reportPublic FDA data

Acyclovir

Product NDC
68071-2526
11-digit product format
680712526
Labeler code
68071
Product ID
68071-2526_2b12a92d-ff22-f428-e063-6294a90a3aee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2526-32023-07-14C16284748780-1f386c649-d9d6-0266-e053-dadaa90a7c1aAcyclovir Capsules, USP Rx only
68071-2526-42023-07-14C16284748780-1f386c649-d9d6-0266-e053-dadaa90a7c1aAcyclovir Capsules, USP Rx only
68071-2526-62023-07-14C16284748780-1f386c649-d9d6-0266-e053-dadaa90a7c1aAcyclovir Capsules, USP Rx only
68071-2526-32023-01-30C16284748780-1f386c649-d9d6-0266-e053-dadaa90a7c1aAcyclovir Capsules, USP Rx only
68071-2526-42023-01-30C16284748780-1f386c649-d9d6-0266-e053-dadaa90a7c1aAcyclovir Capsules, USP Rx only
68071-2526-62023-01-30C16284748780-1f386c649-d9d6-0266-e053-dadaa90a7c1aAcyclovir Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2526-3Acyclovir30 in 1 BOTTLECAPSULE303
68071-2526-4Acyclovir40 in 1 BOTTLECAPSULE403
68071-2526-6Acyclovir60 in 1 BOTTLECAPSULE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2526ACYCLOVIR CAPSULE [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 3 package rows20250108_cacaeb2a-6d3b-cf3e-e053-2a95a90a6ce4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNcacaeb2a-6d3b-cf3e-e053-2a95a90a6ce43
197310acyclovir 200 MG Oral CapsuleSCDcacaeb2a-6d3b-cf3e-e053-2a95a90a6ce43
197310acycycloguanosine 200 MG Oral CapsuleSYcacaeb2a-6d3b-cf3e-e053-2a95a90a6ce43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2526-36807125260330 CAPSULE in 1 BOTTLE (68071-2526-3) 30 capsule2021-08-300000-00-00NoNoCurrent
68071-2526-46807125260440 CAPSULE in 1 BOTTLE (68071-2526-4) 40 capsule2021-08-300000-00-00NoNoCurrent
68071-2526-66807125260660 CAPSULE in 1 BOTTLE (68071-2526-6) 60 capsule2021-08-300000-00-00NoNoCurrent