FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
23155-229
11-digit product format
231550229
Labeler code
23155
Product ID
23155-229_36122e1a-0925-448e-8fae-253b60c49a6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA074889
Marketing category
ANDA
Marketing start
2014-06-02
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-229-01ACYCLOVIR100 in 1 BOTTLECAPSULE1007
23155-229-05ACYCLOVIR500 in 1 BOTTLECAPSULE5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-229-01EA - Each23155-229435aa9f1-04d2-4b91-ad72-e14cd6e9485312018-06-11
23155-229-05EA - Each23155-229a5f6f32c-df98-44fe-a326-a085fed9a49512018-06-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
GELATININACTIVE INGREDIENT2G86QN327LACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35ACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-229ACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 2 package rows20230727_85332671-0e3a-4445-a337-e1266886b9cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN85332671-0e3a-4445-a337-e1266886b9cf7
197310acyclovir 200 MG Oral CapsuleSCD85332671-0e3a-4445-a337-e1266886b9cf7
197310acycycloguanosine 200 MG Oral CapsuleSY85332671-0e3a-4445-a337-e1266886b9cf7
197310acyclovir 200 MG Oral CapsulePSN9b254eed-8ea1-469b-bf27-f5670cd99e8d2
197310acyclovir 200 MG Oral CapsuleSCD9b254eed-8ea1-469b-bf27-f5670cd99e8d2
197310acycycloguanosine 200 MG Oral CapsuleSY9b254eed-8ea1-469b-bf27-f5670cd99e8d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-229-0123155022901100 CAPSULE in 1 BOTTLE (23155-229-01) 100 capsule2014-06-020000-00-00NoNoCurrent
23155-229-0523155022905500 CAPSULE in 1 BOTTLE (23155-229-05) 500 capsule2014-06-020000-00-00NoNoCurrent