FDA.reportPublic FDA data

Acyclovir

Product NDC
71209-004
11-digit product format
712090004
Labeler code
71209
Product ID
71209-004_9b62ab17-f153-447b-b4d6-78dead35afde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA201445
Marketing category
ANDA
Marketing start
2015-12-29
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
71209-004-05Acyclovir100 in 1 BOTTLECAPSULE1007
71209-004-10Acyclovir500 in 1 BOTTLECAPSULE5007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-004ACYCLOVIR CAPSULE [CADILA PHARMACEUTICALS LIMITED]6Current NDC, Legacy NDC, 2 package rows20230306_dbaf4bf5-57e3-4770-a9b2-d47649e54c1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNdbaf4bf5-57e3-4770-a9b2-d47649e54c1b7
197310acyclovir 200 MG Oral CapsuleSCDdbaf4bf5-57e3-4770-a9b2-d47649e54c1b7
197310acycycloguanosine 200 MG Oral CapsuleSYdbaf4bf5-57e3-4770-a9b2-d47649e54c1b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71209-004-0571209000405100 CAPSULE in 1 BOTTLE (71209-004-05) 100 capsule2018-11-200000-00-00NoNoCurrent
71209-004-1071209000410500 CAPSULE in 1 BOTTLE (71209-004-10) 500 capsule2018-11-200000-00-00NoNoCurrent