FDA.reportPublic FDA data

Acyclovir

Product NDC
62135-803
11-digit product format
621350803
Labeler code
62135
Product ID
62135-803_463b5fcf-cfc0-be52-e063-6394a90aa459
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chartwell 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
62135-803-05Acyclovir5 mL in 1 CUPSUSPENSION54
62135-803-20Acyclovir20 mL in 1 CUPSUSPENSION204
62135-803-23Acyclovir2 in 1 BOXSUSPENSION24
62135-803-23Acyclovir10 in 1 TRAYSUSPENSION104
62135-803-24Acyclovir2 in 1 BOXSUSPENSION24
62135-803-24Acyclovir10 in 1 TRAYSUSPENSION104
62135-803-47Acyclovir473 mL in 1 BOTTLESUSPENSION4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-803-05ML - Milliliter62135-8031868a1b7-fe8d-4fd8-b0aa-00b0c669c51f12025-05-14
62135-803-20ML - Milliliter62135-8035a97b68c-0f0b-48d9-bbe4-fc0b0d5ad75712025-05-14
62135-803-23ML - Milliliter62135-8037fbb532d-1987-4843-9d09-106533b924d112025-05-14
62135-803-24ML - Milliliter62135-803dba974aa-1176-4710-a577-29de7f345cb412025-05-14
62135-803-47ML - Milliliter62135-803fa5877b7-06ff-4bab-b71e-cba0d72820f312024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-803ACYCLOVIR SUSPENSION [CHARTWELL RX, LLC]2Current NDC, 7 package rows20250323_7d2a75a5-233f-46dd-9cb0-3918ea53e554.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307730acyclovir 200 MG in 5 mL Oral SuspensionPSN7d2a75a5-233f-46dd-9cb0-3918ea53e5544
307730acyclovir 40 MG/ML Oral SuspensionSCD7d2a75a5-233f-46dd-9cb0-3918ea53e5544
307730acyclovir 200 MG per 5 ML Oral SuspensionSY7d2a75a5-233f-46dd-9cb0-3918ea53e5544
307730acycycloguanosine 40 MG/ML Oral SuspensionSY7d2a75a5-233f-46dd-9cb0-3918ea53e5544

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-803-05621350803055 mL in 1 CUP5 mlHistorical
62135-803-206213508032020 mL in 1 CUP20 mlHistorical
62135-803-23621350803232 TRAY in 1 BOX (62135-803-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-803-20) 2 tray2025-03-20NoNoHistorical
62135-803-24621350803242 TRAY in 1 BOX (62135-803-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-803-05) 2 tray2025-03-20NoNoHistorical
62135-803-4762135080347473 mL in 1 BOTTLE (62135-803-47) 473 ml2023-11-30NoNoHistorical