FDA.reportPublic FDA data

Acyclovir

Product NDC
75834-124
11-digit product format
758340124
Labeler code
75834
Product ID
75834-124_bdd7c1ab-7f2d-43b5-9ff7-238aa1b9576f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA201445
Marketing category
ANDA
Marketing start
2016-10-15
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
75834-124-012022-02-15C16284748780-19d75b9d1-1911-f424-e053-dadaa90a57ceAcyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
75834-124-052022-02-15C16284748780-19d75b9d1-1911-f424-e053-dadaa90a57ceAcyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
75834-124-012022-01-28C16284748780-19d75b9d1-1911-f424-e053-dadaa90a57ceAcyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
75834-124-052022-01-28C16284748780-19d75b9d1-1911-f424-e053-dadaa90a57ceAcyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
75834-124-012020-05-05C16284748780-19d75b9d1-1911-f424-e053-dadaa90a57ceAcyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
75834-124-052020-05-05C16284748780-19d75b9d1-1911-f424-e053-dadaa90a57ceAcyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
75834-124-012020-01-31C16284748780-19d75b9d1-1911-f424-e053-dadaa90a57ceAcyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
75834-124-052020-01-31C16284748780-19d75b9d1-1911-f424-e053-dadaa90a57ceAcyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-124-01Acyclovir100 in 1 BOTTLECAPSULE1004
75834-124-05Acyclovir500 in 1 BOTTLECAPSULE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-124-01EA - Each75834-124df9410d3-1d2a-4551-85ab-71675d863ddb12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-124ACYCLOVIR CAPSULE [NIVAGEN PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20220216_1b0919aa-0d41-4c91-9ef4-049ac9e27d78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN1b0919aa-0d41-4c91-9ef4-049ac9e27d784
197310acyclovir 200 MG Oral CapsulePSN1dc4a821-b0d6-433c-94f4-61c1a479102a4
197310acyclovir 200 MG Oral CapsuleSCD1b0919aa-0d41-4c91-9ef4-049ac9e27d784
197310acyclovir 200 MG Oral CapsuleSCD1dc4a821-b0d6-433c-94f4-61c1a479102a4
197310acycycloguanosine 200 MG Oral CapsuleSY1b0919aa-0d41-4c91-9ef4-049ac9e27d784
197310acycycloguanosine 200 MG Oral CapsuleSY1dc4a821-b0d6-433c-94f4-61c1a479102a4
197310acyclovir 200 MG Oral CapsulePSN9718e55a-433b-6bad-e053-2a95a90af1253
197310acyclovir 200 MG Oral CapsuleSCD9718e55a-433b-6bad-e053-2a95a90af1253
197310acycycloguanosine 200 MG Oral CapsuleSY9718e55a-433b-6bad-e053-2a95a90af1253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-124-0175834012401100 CAPSULE in 1 BOTTLE (75834-124-01) 100 capsule2016-10-150000-00-00NoNoCurrent
75834-124-0575834012405500 CAPSULE in 1 BOTTLE (75834-124-05) 500 capsule2016-10-150000-00-00NoNoCurrent