FDA.reportPublic FDA data

Acyclovir

Product NDC
50090-5610
11-digit product format
500905610
Labeler code
50090
Product ID
50090-5610_a6cc5d9a-f1aa-4ca0-b3de-c7ee13eb9d86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075090
Marketing category
ANDA
Marketing start
2021-05-27
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5610-02023-02-06C16284748780-1f386c649-ccac-0266-e053-dadaa90a7c1aAcyclovir Capsules USP
50090-5610-12023-02-06C16284748780-1f386c649-ccac-0266-e053-dadaa90a7c1aAcyclovir Capsules USP
50090-5610-72023-02-06C16284748780-1f386c649-ccac-0266-e053-dadaa90a7c1aAcyclovir Capsules USP
50090-5610-02023-01-30C16284748780-1f386c649-ccac-0266-e053-dadaa90a7c1aAcyclovir Capsules USP
50090-5610-12023-01-30C16284748780-1f386c649-ccac-0266-e053-dadaa90a7c1aAcyclovir Capsules USP
50090-5610-72023-01-30C16284748780-1f386c649-ccac-0266-e053-dadaa90a7c1aAcyclovir Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5610-0Acyclovir25 in 1 BOTTLECAPSULE255
50090-5610-1Acyclovir50 in 1 BOTTLECAPSULE505
50090-5610-7Acyclovir30 in 1 BOTTLECAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5610-0EA - Each50090-5610101f6e24-e519-4d41-9c67-cceae5e0527712022-12-07
50090-5610-1EA - Each50090-561072a96334-32a0-42b2-a4ff-10588e3ca5d212022-12-07
50090-5610-7EA - Each50090-5610a4a38d0d-d964-4bc5-9eb8-6fa58d1b23cd12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5610ACYCLOVIR CAPSULE [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 3 package rows20240214_6e813b35-4ead-42d6-bc51-9d7caf1db1ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN6e813b35-4ead-42d6-bc51-9d7caf1db1ef5
197310acyclovir 200 MG Oral CapsuleSCD6e813b35-4ead-42d6-bc51-9d7caf1db1ef5
197310acycycloguanosine 200 MG Oral CapsuleSY6e813b35-4ead-42d6-bc51-9d7caf1db1ef5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5610-05009056100025 CAPSULE in 1 BOTTLE (50090-5610-0) 25 capsule2021-08-050000-00-00NoNoCurrent
50090-5610-15009056100150 CAPSULE in 1 BOTTLE (50090-5610-1) 50 capsule2021-08-050000-00-00NoNoCurrent
50090-5610-75009056100730 CAPSULE in 1 BOTTLE (50090-5610-7) 30 capsule2021-08-050000-00-00NoNoCurrent