FDA.reportPublic FDA data

acyclovir

Product NDC
50090-7216
11-digit product format
500907216
Labeler code
50090
Product ID
50090-7216_a7a1c1f7-205c-4516-803b-3e06408b9941
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204313
Marketing category
ANDA
Marketing start
2019-08-23
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
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
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
50090-7216-0acyclovir25 in 1 BOTTLECAPSULE253
50090-7216-1acyclovir50 in 1 BOTTLECAPSULE503
50090-7216-7acyclovir30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7216-0EA - Each50090-7216fb3db07a-80af-4620-a7c1-a8fbf9f5c16b12024-09-09
50090-7216-1EA - Each50090-7216ad1669e4-9bff-4920-ad17-09eaed36214e12024-09-09
50090-7216-7EA - Each50090-7216ae69e12f-4c3b-4343-9d53-f8fea542744312024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7216ACYCLOVIR CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20240813_a0ed999f-7366-42c3-a6f5-3c239215a99c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNa0ed999f-7366-42c3-a6f5-3c239215a99c3
197310acyclovir 200 MG Oral CapsuleSCDa0ed999f-7366-42c3-a6f5-3c239215a99c3
197310acycycloguanosine 200 MG Oral CapsuleSYa0ed999f-7366-42c3-a6f5-3c239215a99c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7216-05009072160025 CAPSULE in 1 BOTTLE (50090-7216-0) 25 capsule2024-08-07NoNoCurrent
50090-7216-15009072160150 CAPSULE in 1 BOTTLE (50090-7216-1) 50 capsule2024-08-07NoNoCurrent
50090-7216-75009072160730 CAPSULE in 1 BOTTLE (50090-7216-7) 30 capsule2024-08-07NoNoCurrent