FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
0904-5789
11-digit product format
009045789
Labeler code
0904
Product ID
0904-5789_47ed6bd7-4c02-404c-baf2-8ad542eb36df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA075677
Marketing category
ANDA
Marketing start
2006-03-20
Marketing end
2026-08-31
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
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075677-001ACYCLOVIRACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075677-001AB

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 22:54:322026-06A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075677-001AB1a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACYCLOVIRACYCLOVIRBryant Ranch Prepack2b600b5d-ce91-461f-b9d1-75b969daf8e92026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075677
application number: ANDA075677
ACYCLOVIRACYCLOVIRMajor Pharmaceuticals864d96b9-e2de-45a8-850b-6f7b72ceefe12026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075677
application number: ANDA075677
ndc (product): 0904-5789
ACYCLOVIRACYCLOVIRCardinal Health 107, LLC7484b631-18f9-440d-bb11-a44932fec6e72026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075677
application number: ANDA075677
ACYCLOVIRACYCLOVIRBryant Ranch Prepacke5356160-cb35-4ff6-91d5-2ade594e02792026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075677
application number: ANDA075677
ACYCLOVIRACYCLOVIRApotex Corp.41bea43a-f58c-2c6f-4d31-406ceb4560772025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075677
application number: ANDA075677
ACYCLOVIRACYCLOVIRProficient Rx LP8d7994a6-5bd2-494d-89c1-b03755d4f2c32020-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075677
application number: ANDA075677

Additional Listing Data#

Finished product
Yes
Brand name base
ACYCLOVIR

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR200 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197310Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
864d96b9-e2de-45a8-850b-6f7b72ceefe1Available 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
0904-5789-61ACYCLOVIR100 in 1 CARTONCAPSULE1009
0904-5789-61ACYCLOVIR1 in 1 BLISTER PACKCAPSULE19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5789-61EA - Each0904-578930493d93-5f21-4bdd-9d75-71ce43c36de012013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
GELATININACTIVE INGREDIENT2G86QN327LACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
SHELLACINACTIVE INGREDIENT46N107B71OACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5789ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]7Current NDC, Legacy NDC, 2 package rows20241025_864d96b9-e2de-45a8-850b-6f7b72ceefe1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN7484b631-18f9-440d-bb11-a44932fec6e715
197310acyclovir 200 MG Oral CapsuleSCD7484b631-18f9-440d-bb11-a44932fec6e715
197310acycycloguanosine 200 MG Oral CapsuleSY7484b631-18f9-440d-bb11-a44932fec6e715
197310acyclovir 200 MG Oral CapsulePSN864d96b9-e2de-45a8-850b-6f7b72ceefe19
197310acyclovir 200 MG Oral CapsuleSCD864d96b9-e2de-45a8-850b-6f7b72ceefe19
197310acycycloguanosine 200 MG Oral CapsuleSY864d96b9-e2de-45a8-850b-6f7b72ceefe19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5789-6100904578961100 BLISTER PACK in 1 CARTON (0904-5789-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2006-03-202026-08-31NoNoCurrent