FDA.reportPublic FDA data

acyclovir

Product NDC
68382-792
11-digit product format
683820792
Labeler code
68382
Product ID
68382-792_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
800 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
ACYCLOVIR800 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
68382-792-01acyclovir100 in 1 BOTTLETABLET1005
68382-792-05acyclovir500 in 1 BOTTLETABLET5005
68382-792-06acyclovir30 in 1 BOTTLETABLET305
68382-792-10acyclovir1000 in 1 BOTTLETABLET10005
68382-792-16acyclovir90 in 1 BOTTLETABLET905
68382-792-30acyclovir10 in 1 CARTONTABLET105
68382-792-30acyclovir10 in 1 BLISTER PACKTABLET105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-792-01EA - Each68382-792400e0f9c-5978-44d7-a806-0ace6bdace9c12014-11-05
68382-792-05EA - Each68382-7927704dbdf-500d-43ff-aea1-675cfbbcc52112014-11-05

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
68382-792ACYCLOVIR 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
197313acyclovir 800 MG Oral TabletPSN960e4ede-692e-4db2-a96e-dc6f4a6190ee7
197313acyclovir 800 MG Oral TabletPSNd2a287f7-98c4-4a34-ad4c-e8a5dccc8a3f7
197313acyclovir 800 MG Oral TabletSCD960e4ede-692e-4db2-a96e-dc6f4a6190ee7
197313acyclovir 800 MG Oral TabletSCDd2a287f7-98c4-4a34-ad4c-e8a5dccc8a3f7
197313acycycloguanosine 800 MG Oral TabletSY960e4ede-692e-4db2-a96e-dc6f4a6190ee7
197313acycycloguanosine 800 MG Oral TabletSYd2a287f7-98c4-4a34-ad4c-e8a5dccc8a3f7
197311acyclovir 400 MG Oral TabletPSNedb0cd28-ee57-4b60-be94-62c797fbf5e65
197313acyclovir 800 MG Oral TabletPSN40e5cc54-ed74-3369-e054-00144ff88e885
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
197313acyclovir 800 MG Oral TabletSCD40e5cc54-ed74-3369-e054-00144ff88e885
197311acycycloguanosine 400 MG Oral TabletSYedb0cd28-ee57-4b60-be94-62c797fbf5e65
197313acycycloguanosine 800 MG Oral TabletSY40e5cc54-ed74-3369-e054-00144ff88e885
197313acycycloguanosine 800 MG Oral TabletSYedb0cd28-ee57-4b60-be94-62c797fbf5e65
197313acyclovir 800 MG Oral TabletPSN68062f0d-b4ae-72de-e053-2991aa0a00543
197313acyclovir 800 MG Oral TabletPSN3da54b2d-a206-4ff5-8cc2-90762c4fd70d3
197313acyclovir 800 MG Oral TabletSCD68062f0d-b4ae-72de-e053-2991aa0a00543
197313acyclovir 800 MG Oral TabletSCD3da54b2d-a206-4ff5-8cc2-90762c4fd70d3
197313acycycloguanosine 800 MG Oral TabletSY68062f0d-b4ae-72de-e053-2991aa0a00543
197313acycycloguanosine 800 MG Oral TabletSY3da54b2d-a206-4ff5-8cc2-90762c4fd70d3
197311acyclovir 400 MG Oral TabletPSN686c68c4-53d9-6d58-e053-2a91aa0aa7461
197313acyclovir 800 MG Oral TabletPSN686c68c4-53d9-6d58-e053-2a91aa0aa7461
197313acyclovir 800 MG Oral TabletPSN50c58161-3944-7367-e063-6394a90a62861
197313acyclovir 800 MG Oral TabletPSN3f6d9728-5f8c-4a6f-8295-612f39f76fdb1
197313acyclovir 800 MG Oral TabletPSN2cdbea8d-29df-0045-e063-6294a90a95061
197311acyclovir 400 MG Oral TabletSCD686c68c4-53d9-6d58-e053-2a91aa0aa7461
197313acyclovir 800 MG Oral TabletSCD686c68c4-53d9-6d58-e053-2a91aa0aa7461
197313acyclovir 800 MG Oral TabletSCD2cdbea8d-29df-0045-e063-6294a90a95061
197313acyclovir 800 MG Oral TabletSCD50c58161-3944-7367-e063-6394a90a62861
197313acyclovir 800 MG Oral TabletSCD3f6d9728-5f8c-4a6f-8295-612f39f76fdb1
197311acycycloguanosine 400 MG Oral TabletSY686c68c4-53d9-6d58-e053-2a91aa0aa7461
197313acycycloguanosine 800 MG Oral TabletSY686c68c4-53d9-6d58-e053-2a91aa0aa7461
197313acycycloguanosine 800 MG Oral TabletSY50c58161-3944-7367-e063-6394a90a62861
197313acycycloguanosine 800 MG Oral TabletSY3f6d9728-5f8c-4a6f-8295-612f39f76fdb1
197313acycycloguanosine 800 MG Oral TabletSY2cdbea8d-29df-0045-e063-6294a90a95061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-792-0168382079201100 TABLET in 1 BOTTLE (68382-792-01) 100 tablet2014-09-100000-00-00NoNoCurrent
68382-792-0568382079205500 TABLET in 1 BOTTLE (68382-792-05) 500 tablet2014-09-100000-00-00NoNoCurrent
68382-792-066838207920630 TABLET in 1 BOTTLE (68382-792-06) 30 tablet2014-09-100000-00-00NoNoCurrent
68382-792-10683820792101000 TABLET in 1 BOTTLE (68382-792-10) 1000 tablet2014-09-100000-00-00NoNoCurrent
68382-792-166838207921690 TABLET in 1 BOTTLE (68382-792-16) 90 tablet2014-09-100000-00-00NoNoCurrent
68382-792-306838207923010 BLISTER PACK in 1 CARTON (68382-792-30) / 10 TABLET in 1 BLISTER PACK10 blister pack2014-09-100000-00-00NoNoCurrent