FDA.reportPublic FDA data

Acyclovir

Product NDC
50268-061
11-digit product format
502680061
Labeler code
50268
Product ID
50268-061_47e22393-03a9-791e-e063-6294a90aa89a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA075382
Marketing category
ANDA
Marketing start
2011-03-16
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075382-001ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB1999-04-30
A075382-002ACYCLOVIRACYCLOVIR800MGTABLET / ORALAB1999-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075382-001AB
A075382-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30a50c72e98297…
2026-08-01 22:54:322026-06A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075382-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075382-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcyclovirACYCLOVIRCardinal Health 107, LLCd8004652-86fe-4714-81d4-5e1dd2585bb42026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.c2d9940a-ce88-5fd0-e053-2a95a90a4bc82026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRAvPAK6e203fa9-ee97-1e08-8d6a-fb57cfa13e192026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
ndc (product): 50268-061
AcyclovirACYCLOVIRBryant Ranch Prepackf3cbd634-77c8-3306-bdbd-a4598b20603e2024-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepacke0f17e6f-63c7-4828-8585-91fc582df30b2024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepackf09cdb3f-dfd2-4e47-bb5e-a5d26d8bcc892024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepack8c5d1f30-2d31-417d-860b-7228b7baaa642024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRGolden State Medical Supply, Inc.785d68bc-0bbf-b69d-e053-2991aa0ac0d52024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepack89583890-186b-4a7a-8741-41f6c5f0a99d2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRCarlsbad Technology, Inc.a68e610a-841c-4b69-9233-673d060561e82024-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.c46d5033-b1b2-e213-e053-2995a90ae6a32024-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRProficient Rx LP33630a35-346e-43b6-9286-89e28ac0094a2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382

Additional Listing Data#

Finished product
Yes
Brand name base
Acyclovir
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X4HES1O11FInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197311Internal RxNorm lookup
197313Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6e203fa9-ee97-1e08-8d6a-fb57cfa13e19Available on FDA.report

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
50268-061-11Acyclovir1 in 1 BLISTER PACKTABLET116
50268-061-15Acyclovir50 in 1 BOTTLE, UNIT-DOSETABLET5016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-061-11EA - Each50268-061ecf90e4e-1ad7-4f49-9b27-670b998f548412015-04-03
50268-061-15EA - Each50268-0617fc1697a-9723-45b1-8320-d4db7f884ce512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
Starch, CornINACTIVE INGREDIENTO8232NY3SJACYCLOVIR (ACYCLOVIR) TABLET [AVPAK]11
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [CARDINAL HEALTH]2
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [CARDINAL HEALTH]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [CARDINAL HEALTH]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [CARDINAL HEALTH]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [CARDINAL HEALTH]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJACYCLOVIR TABLET [CARDINAL HEALTH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-061ACYCLOVIR TABLET [AVPAK]15Current NDC, Legacy NDC, 2 package rows20231018_6e203fa9-ee97-1e08-8d6a-fb57cfa13e19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916
197311acyclovir 400 MG Oral TabletPSNd8004652-86fe-4714-81d4-5e1dd2585bb416
197313acyclovir 800 MG Oral TabletPSN6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916
197311acyclovir 400 MG Oral TabletSCD6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916
197311acyclovir 400 MG Oral TabletSCDd8004652-86fe-4714-81d4-5e1dd2585bb416
197313acyclovir 800 MG Oral TabletSCD6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916
197311acycycloguanosine 400 MG Oral TabletSY6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916
197311acycycloguanosine 400 MG Oral TabletSYd8004652-86fe-4714-81d4-5e1dd2585bb416
197313acycycloguanosine 800 MG Oral TabletSY6e203fa9-ee97-1e08-8d6a-fb57cfa13e1916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-061-11502680061111 in 1 BLISTER PACKHistorical
50268-061-155026800611550 BLISTER PACK in 1 BOTTLE, UNIT-DOSE (50268-061-15) / 1 TABLET in 1 BLISTER PACK (50268-061-11) 50 blister pack2011-03-160000-00-00NoNoCurrent