FDA.reportPublic FDA data

Acyclovir

Product NDC
61442-114
11-digit product format
614420114
Labeler code
61442
Product ID
61442-114_209d3e94-5d8e-8799-e063-6394a90ab9d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Carlsbad Technology, Inc.
Application
ANDA206261
Marketing category
ANDA
Marketing start
2017-08-17
Substance
ACYCLOVIR
Active strength
200 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
ACYCLOVIR200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197310

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
61442-114-01Acyclovir100 in 1 BOTTLE, PLASTICCAPSULE1008
61442-114-01Acyclovir12 in 1 BOXCAPSULE128
61442-114-05Acyclovir500 in 1 BOTTLE, PLASTICCAPSULE5008
61442-114-05Acyclovir12 in 1 BOXCAPSULE128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61442-114-01EA - Each61442-11480b6730d-c9b0-45f1-a11e-7b96239d351412018-04-19
61442-114-05EA - Each61442-1143b6047df-c666-4a10-aa92-49daebf233b812018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61442-114ACYCLOVIR CAPSULE [CARLSBAD TECHNOLOGY, INC.]8Current NDC, Legacy NDC, 4 package rows20240828_37499620-6a17-40f1-b0db-dd79320ea21d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNaf9d41f5-4658-4487-8811-32a1f8af9384104
197310acyclovir 200 MG Oral CapsuleSCDaf9d41f5-4658-4487-8811-32a1f8af9384104
197310acycycloguanosine 200 MG Oral CapsuleSYaf9d41f5-4658-4487-8811-32a1f8af9384104
197310acyclovir 200 MG Oral CapsulePSN37499620-6a17-40f1-b0db-dd79320ea21d8
197310acyclovir 200 MG Oral CapsuleSCD37499620-6a17-40f1-b0db-dd79320ea21d8
197310acycycloguanosine 200 MG Oral CapsuleSY37499620-6a17-40f1-b0db-dd79320ea21d8
197310acyclovir 200 MG Oral CapsulePSN01ae85df-d1a0-44f7-b4c0-0ac74d2216d47
197310acyclovir 200 MG Oral CapsuleSCD01ae85df-d1a0-44f7-b4c0-0ac74d2216d47
197310acycycloguanosine 200 MG Oral CapsuleSY01ae85df-d1a0-44f7-b4c0-0ac74d2216d47
197310acyclovir 200 MG Oral CapsulePSNb455053f-3deb-bd76-e053-2a95a90a98693
197310acyclovir 200 MG Oral CapsulePSN0d99ba77-c3c5-1fd0-e063-6294a90a6f2a3
197310acyclovir 200 MG Oral CapsulePSN5526d42c-fc09-4a59-8acf-b15257c73d0e3
197310acyclovir 200 MG Oral CapsuleSCD0d99ba77-c3c5-1fd0-e063-6294a90a6f2a3
197310acyclovir 200 MG Oral CapsuleSCD5526d42c-fc09-4a59-8acf-b15257c73d0e3
197310acyclovir 200 MG Oral CapsuleSCDb455053f-3deb-bd76-e053-2a95a90a98693
197310acycycloguanosine 200 MG Oral CapsuleSY5526d42c-fc09-4a59-8acf-b15257c73d0e3
197310acycycloguanosine 200 MG Oral CapsuleSYb455053f-3deb-bd76-e053-2a95a90a98693
197310acycycloguanosine 200 MG Oral CapsuleSY0d99ba77-c3c5-1fd0-e063-6294a90a6f2a3
197310acyclovir 200 MG Oral CapsulePSNe8056ec6-d2dc-48af-8550-82726af1c5c52
197310acyclovir 200 MG Oral CapsuleSCDe8056ec6-d2dc-48af-8550-82726af1c5c52
197310acycycloguanosine 200 MG Oral CapsuleSYe8056ec6-d2dc-48af-8550-82726af1c5c52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61442-114-016144201140112 BOTTLE, PLASTIC in 1 BOX (61442-114-01) / 100 CAPSULE in 1 BOTTLE, PLASTIC2017-08-170000-00-00NoNoCurrent
61442-114-056144201140512 BOTTLE, PLASTIC in 1 BOX (61442-114-05) / 500 CAPSULE in 1 BOTTLE, PLASTIC2017-08-170000-00-00NoNoCurrent