FDA.reportPublic FDA data

acyclovir

Product NDC
68382-791
11-digit product format
683820791
Labeler code
68382
Product ID
68382-791_d8791a7b-225c-4f2e-9023-1a1932b0f7d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA204314
Marketing category
ANDA
Marketing start
2014-09-10
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
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
ACYCLOVIR400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197311, 197313

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
68382-791-01acyclovir100 in 1 BOTTLETABLET1005
68382-791-05acyclovir500 in 1 BOTTLETABLET5005
68382-791-06acyclovir30 in 1 BOTTLETABLET305
68382-791-10acyclovir1000 in 1 BOTTLETABLET10005
68382-791-16acyclovir90 in 1 BOTTLETABLET905
68382-791-30acyclovir10 in 1 BLISTER PACKTABLET105
68382-791-30acyclovir10 in 1 CARTONTABLET105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-791-01EA - Each68382-79117f9aba5-3aa8-49c6-ab9c-a9ff52e9081512014-11-05
68382-791-05EA - Each68382-79167e52610-096e-4252-9447-70087b7e20fb12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-791ACYCLOVIR TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]4Current NDC, Legacy NDC, 7 package rows20231025_edb0cd28-ee57-4b60-be94-62c797fbf5e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNc40a57b9-4cf1-4a69-abf3-eb99a7fcda009
197311acyclovir 400 MG Oral TabletSCDc40a57b9-4cf1-4a69-abf3-eb99a7fcda009
197311acycycloguanosine 400 MG Oral TabletSYc40a57b9-4cf1-4a69-abf3-eb99a7fcda009
197311acyclovir 400 MG Oral TabletPSNf3e6b1ad-810b-4f53-b92a-b28fc2111f3f8
197311acyclovir 400 MG Oral TabletPSN8fdabab2-bc93-48ab-9c13-d22ec90fdcfc8
197311acyclovir 400 MG Oral TabletSCDf3e6b1ad-810b-4f53-b92a-b28fc2111f3f8
197311acyclovir 400 MG Oral TabletSCD8fdabab2-bc93-48ab-9c13-d22ec90fdcfc8
197311acycycloguanosine 400 MG Oral TabletSYf3e6b1ad-810b-4f53-b92a-b28fc2111f3f8
197311acycycloguanosine 400 MG Oral TabletSY8fdabab2-bc93-48ab-9c13-d22ec90fdcfc8
197311acyclovir 400 MG Oral TabletPSNedb0cd28-ee57-4b60-be94-62c797fbf5e65
197313acyclovir 800 MG Oral TabletPSNedb0cd28-ee57-4b60-be94-62c797fbf5e65
197311acyclovir 400 MG Oral TabletSCDedb0cd28-ee57-4b60-be94-62c797fbf5e65
197313acyclovir 800 MG Oral TabletSCDedb0cd28-ee57-4b60-be94-62c797fbf5e65
197311acycycloguanosine 400 MG Oral TabletSYedb0cd28-ee57-4b60-be94-62c797fbf5e65
197313acycycloguanosine 800 MG Oral TabletSYedb0cd28-ee57-4b60-be94-62c797fbf5e65
197311acyclovir 400 MG Oral TabletPSN5c50afc5-12fb-86f5-e053-2a91aa0a350b3
197311acyclovir 400 MG Oral TabletSCD5c50afc5-12fb-86f5-e053-2a91aa0a350b3
197311acycycloguanosine 400 MG Oral TabletSY5c50afc5-12fb-86f5-e053-2a91aa0a350b3
197311acyclovir 400 MG Oral TabletPSN3399cc2e-8596-450d-91df-434dac0aab851
197311acyclovir 400 MG Oral TabletPSN6c5662a1-df2e-a627-e053-2a91aa0a78441
197311acyclovir 400 MG Oral TabletPSN686c68c4-53d9-6d58-e053-2a91aa0aa7461
197313acyclovir 800 MG Oral TabletPSN686c68c4-53d9-6d58-e053-2a91aa0aa7461
197311acyclovir 400 MG Oral TabletSCD6c5662a1-df2e-a627-e053-2a91aa0a78441
197311acyclovir 400 MG Oral TabletSCD3399cc2e-8596-450d-91df-434dac0aab851
197311acyclovir 400 MG Oral TabletSCD686c68c4-53d9-6d58-e053-2a91aa0aa7461
197313acyclovir 800 MG Oral TabletSCD686c68c4-53d9-6d58-e053-2a91aa0aa7461
197311acycycloguanosine 400 MG Oral TabletSY6c5662a1-df2e-a627-e053-2a91aa0a78441
197311acycycloguanosine 400 MG Oral TabletSY686c68c4-53d9-6d58-e053-2a91aa0aa7461
197311acycycloguanosine 400 MG Oral TabletSY3399cc2e-8596-450d-91df-434dac0aab851
197313acycycloguanosine 800 MG Oral TabletSY686c68c4-53d9-6d58-e053-2a91aa0aa7461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-791-0168382079101100 TABLET in 1 BOTTLE (68382-791-01) 100 tablet2014-09-100000-00-00NoNoCurrent
68382-791-0568382079105500 TABLET in 1 BOTTLE (68382-791-05) 500 tablet2014-09-100000-00-00NoNoCurrent
68382-791-066838207910630 TABLET in 1 BOTTLE (68382-791-06) 30 tablet2014-09-100000-00-00NoNoCurrent
68382-791-10683820791101000 TABLET in 1 BOTTLE (68382-791-10) 1000 tablet2014-09-100000-00-00NoNoCurrent
68382-791-166838207911690 TABLET in 1 BOTTLE (68382-791-16) 90 tablet2014-09-100000-00-00NoNoCurrent
68382-791-306838207913010 BLISTER PACK in 1 CARTON (68382-791-30) / 10 TABLET in 1 BLISTER PACK10 blister pack2014-09-100000-00-00NoNoCurrent