FDA.reportPublic FDA data

Acyclovir

Product NDC
43063-928
11-digit product format
430630928
Labeler code
43063
Product ID
43063-928_415e6410-928c-0b21-e063-6294a90a183c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, 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
2027-12-31

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
43063-928-04Acyclovir4 in 1 BOTTLE, PLASTICTABLET419
43063-928-05Acyclovir5 in 1 BOTTLE, PLASTICTABLET519
43063-928-15Acyclovir15 in 1 BOTTLE, PLASTICTABLET1519
43063-928-25Acyclovir25 in 1 BOTTLE, PLASTICTABLET2519
43063-928-30Acyclovir30 in 1 BOTTLE, PLASTICTABLET3019
43063-928-40Acyclovir40 in 1 BOTTLE, PLASTICTABLET4019
43063-928-60Acyclovir60 in 1 BOTTLE, PLASTICTABLET6019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-928-04EA - Each43063-92833efad0e-4ea5-4984-a782-913b1b7a595912020-02-13
43063-928-05EA - Each43063-928fb1180ca-8d73-491e-b8b5-90aa526605ad12023-12-05
43063-928-15EA - Each43063-928ed58583e-dc50-47dd-831b-0c90489b789412019-04-11
43063-928-25EA - Each43063-928de824b97-8330-4250-9c0f-693ed8e35c3e12019-03-12
43063-928-30EA - Each43063-928dc3e15cd-90be-4f34-b698-64465829aaed12019-02-13
43063-928-40EA - Each43063-9285caa244b-81d4-40fc-b129-7bc0e91aa12212019-05-02
43063-928-60EA - Each43063-92869421b4c-f4a3-4647-ad1e-4aae74c1269412019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-928ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 7 package rows20241018_db0a0ce5-dc39-4bd3-8b97-21ce9c9999f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNdb0a0ce5-dc39-4bd3-8b97-21ce9c9999f019
197311acyclovir 400 MG Oral TabletSCDdb0a0ce5-dc39-4bd3-8b97-21ce9c9999f019
197311acycycloguanosine 400 MG Oral TabletSYdb0a0ce5-dc39-4bd3-8b97-21ce9c9999f019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-928-04430630928044 TABLET in 1 BOTTLE, PLASTIC (43063-928-04) 4 tablet2020-06-180000-00-00NoNoCurrent
43063-928-05430630928055 TABLET in 1 BOTTLE, PLASTIC (43063-928-05) 5 tablet2023-10-30NoNoCurrent
43063-928-154306309281515 TABLET in 1 BOTTLE, PLASTIC (43063-928-15) 15 tablet2019-02-130000-00-00NoNoCurrent
43063-928-254306309282525 TABLET in 1 BOTTLE, PLASTIC (43063-928-25) 25 tablet2019-01-250000-00-00NoNoCurrent
43063-928-304306309283030 TABLET in 1 BOTTLE, PLASTIC (43063-928-30) 30 tablet2019-01-160000-00-00NoNoCurrent
43063-928-404306309284040 TABLET in 1 BOTTLE, PLASTIC (43063-928-40) 40 tablet2019-03-290000-00-00NoNoCurrent
43063-928-604306309286060 TABLET in 1 BOTTLE, PLASTIC (43063-928-60) 60 tablet2019-01-090000-00-00NoNoCurrent