FDA.reportPublic FDA data

Acyclovir

Product NDC
54348-627
11-digit product format
543480627
Labeler code
54348
Product ID
54348-627_ea937906-dba1-207f-e053-2a95a90a111e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
PharmPak, Inc.
Application
ANDA203834
Marketing category
ANDA
Marketing start
2013-11-29
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

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
54348-627-10Acyclovir1 in 1 BOXTABLET12
54348-627-10Acyclovir10 in 1 BOTTLETABLET102
54348-627-15Acyclovir1 in 1 BOXTABLET12
54348-627-15Acyclovir15 in 1 BOTTLETABLET152
54348-627-20Acyclovir20 in 1 BOTTLETABLET202
54348-627-20Acyclovir1 in 1 BOXTABLET12
54348-627-21Acyclovir21 in 1 BOTTLETABLET212
54348-627-21Acyclovir1 in 1 BOXTABLET12
54348-627-25Acyclovir25 in 1 BOTTLETABLET252
54348-627-25Acyclovir1 in 1 BOXTABLET12
54348-627-30Acyclovir30 in 1 BOTTLETABLET302
54348-627-30Acyclovir1 in 1 BOXTABLET12
54348-627-60Acyclovir60 in 1 BOTTLETABLET602
54348-627-60Acyclovir1 in 1 BOXTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54348-627ACYCLOVIR TABLET [PHARMPAK, INC.]2Current NDC, Legacy NDC, 14 package rows20221011_8fb01f23-e2bd-6850-e053-2995a90a7cc5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN8fb01f23-e2bd-6850-e053-2995a90a7cc52
197311acyclovir 400 MG Oral TabletSCD8fb01f23-e2bd-6850-e053-2995a90a7cc52
197311acycycloguanosine 400 MG Oral TabletSY8fb01f23-e2bd-6850-e053-2995a90a7cc52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54348-627-10543480627101 BOTTLE in 1 BOX (54348-627-10) / 10 TABLET in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent
54348-627-15543480627151 BOTTLE in 1 BOX (54348-627-15) / 15 TABLET in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent
54348-627-20543480627201 BOTTLE in 1 BOX (54348-627-20) / 20 TABLET in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent
54348-627-21543480627211 BOTTLE in 1 BOX (54348-627-21) / 21 TABLET in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent
54348-627-25543480627251 BOTTLE in 1 BOX (54348-627-25) / 25 TABLET in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent
54348-627-30543480627301 BOTTLE in 1 BOX (54348-627-30) / 30 TABLET in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent
54348-627-60543480627601 BOTTLE in 1 BOX (54348-627-60) / 60 TABLET in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent