FDA.reportPublic FDA data

Acyclovir

Product NDC
68999-803
11-digit product format
689990803
Labeler code
68999
Product ID
68999-803_46a3a089-45f8-184c-e063-6294a90a9bc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chartwell Governmental & Specialty RX, LLC.
Application
ANDA212718
Marketing category
ANDA
Marketing start
2020-04-23
Substance
ACYCLOVIR
Active strength
200 mg/5mL
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
ACYCLOVIR200 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui307730

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
68999-803-05Acyclovir5 mL in 1 CUPSUSPENSION51
68999-803-20Acyclovir20 mL in 1 CUPSUSPENSION201
68999-803-23Acyclovir10 in 1 TRAYSUSPENSION101
68999-803-23Acyclovir2 in 1 BOXSUSPENSION21
68999-803-24Acyclovir10 in 1 TRAYSUSPENSION101
68999-803-24Acyclovir2 in 1 BOXSUSPENSION21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68999-803-05ML - Milliliter68999-803271b8197-8986-496b-94d1-d1ae4d55f7f012026-03-17
68999-803-20ML - Milliliter68999-803ef914da3-9819-4c70-8dc5-4fd2bf99caed12026-03-17
68999-803-23ML - Milliliter68999-803eb160a02-2ca1-4529-96e7-e23af5e36cc412026-03-17
68999-803-24ML - Milliliter68999-8034602e8cc-7e17-4e4b-b24f-c95396d1dfd112026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307730acyclovir 200 MG in 5 mL Oral SuspensionPSN2757bb30-3374-4e1b-b496-14874f7ec6231
307730acyclovir 40 MG/ML Oral SuspensionSCD2757bb30-3374-4e1b-b496-14874f7ec6231
307730acyclovir 200 MG per 5 ML Oral SuspensionSY2757bb30-3374-4e1b-b496-14874f7ec6231
307730acycycloguanosine 40 MG/ML Oral SuspensionSY2757bb30-3374-4e1b-b496-14874f7ec6231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-803-05689990803055 mL in 1 CUP5 mlHistorical
68999-803-206899908032020 mL in 1 CUP20 mlHistorical
68999-803-23689990803232 TRAY in 1 BOX (68999-803-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (68999-803-20) 2 tray2025-12-19NoNoHistorical
68999-803-24689990803242 TRAY in 1 BOX (68999-803-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-803-05) 2 tray2025-12-19NoNoHistorical