FDA.reportPublic FDA data

Acyclovir

Product NDC
68788-7575
11-digit product format
687887575
Labeler code
68788
Product ID
68788-7575_9248c792-3664-4f8e-9d1d-3c4344deb9fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA203834
Marketing category
ANDA
Marketing start
2013-11-29
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
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
ACYCLOVIR800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197313

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
68788-7575-2Acyclovir21 in 1 BOTTLETABLET217
68788-7575-3Acyclovir30 in 1 BOTTLETABLET307
68788-7575-4Acyclovir40 in 1 BOTTLETABLET407
68788-7575-5Acyclovir50 in 1 BOTTLETABLET507
68788-7575-6Acyclovir60 in 1 BOTTLETABLET607
68788-7575-7Acyclovir25 in 1 BOTTLETABLET257
68788-7575-8Acyclovir35 in 1 BOTTLETABLET357

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7575-2EA - Each68788-75756664b73b-5079-4296-8693-84cc83ddf6b812020-09-14
68788-7575-3EA - Each68788-7575e2162436-b189-4de0-8e86-5b4747e7868912020-09-14
68788-7575-4EA - Each68788-7575727d5e08-447f-4456-9713-72f612fae59f12020-09-14
68788-7575-5EA - Each68788-7575daa31903-2716-41b2-aa4d-6469539859fd12020-09-14
68788-7575-6EA - Each68788-75753d509485-1e81-4196-81fc-3c6b0d45773212020-09-14
68788-7575-7EA - Each68788-7575d3a4ca0b-91fb-476a-a8a3-2214e4321fe112020-09-14
68788-7575-8EA - Each68788-75757ad34b91-e710-497f-978f-d2c558094b5b12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7575ACYCLOVIR TABLET [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 7 package rows20250104_b6d69697-12bb-4548-a6c3-2463cbf54f8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSNb6d69697-12bb-4548-a6c3-2463cbf54f8f7
197313acyclovir 800 MG Oral TabletSCDb6d69697-12bb-4548-a6c3-2463cbf54f8f7
197313acycycloguanosine 800 MG Oral TabletSYb6d69697-12bb-4548-a6c3-2463cbf54f8f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7575-26878875750221 TABLET in 1 BOTTLE (68788-7575-2) 21 tablet2019-12-270000-00-00NoNoCurrent
68788-7575-36878875750330 TABLET in 1 BOTTLE (68788-7575-3) 30 tablet2019-12-270000-00-00NoNoCurrent
68788-7575-46878875750440 TABLET in 1 BOTTLE (68788-7575-4) 40 tablet2019-12-270000-00-00NoNoCurrent
68788-7575-56878875750550 TABLET in 1 BOTTLE (68788-7575-5) 50 tablet2019-12-270000-00-00NoNoCurrent
68788-7575-66878875750660 TABLET in 1 BOTTLE (68788-7575-6) 60 tablet2019-12-270000-00-00NoNoCurrent
68788-7575-76878875750725 TABLET in 1 BOTTLE (68788-7575-7) 25 tablet2019-12-270000-00-00NoNoCurrent
68788-7575-86878875750835 TABLET in 1 BOTTLE (68788-7575-8) 35 tablet2019-12-270000-00-00NoNoCurrent