FDA.reportPublic FDA data

Acyclovir

Product NDC
51672-1360
11-digit product format
516721360
Labeler code
51672
Product ID
51672-1360_3ff34f4c-91c2-acec-e063-6394a90a722b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA205469
Marketing category
ANDA
Marketing start
2016-12-21
Substance
ACYCLOVIR
Active strength
50 mg/g
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
ACYCLOVIR50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197312

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
51672-1360-1Acyclovir15 g in 1 TUBEOINTMENT155
51672-1360-1Acyclovir1 in 1 CARTONOINTMENT15
51672-1360-2Acyclovir30 g in 1 TUBEOINTMENT305
51672-1360-2Acyclovir1 in 1 CARTONOINTMENT15
51672-1360-5Acyclovir1 in 1 CARTONOINTMENT15
51672-1360-5Acyclovir5 g in 1 TUBEOINTMENT55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1360-1GM - Gram51672-136003d1dfa6-12c1-4688-8c5e-6082116aa76f12017-03-06
51672-1360-2GM - Gram51672-13603ab83581-69ee-40d4-bb74-dd7af371494a12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1360ACYCLOVIR OINTMENT [SUN PHARMACEUTICAL INDUSTRIES, INC.]3Current NDC, Legacy NDC, 6 package rows20250406_962b2e1a-ba9d-4b39-b6d1-203947166482.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197312acyclovir 5 % Topical OintmentPSN962b2e1a-ba9d-4b39-b6d1-2039471664825
197312acyclovir 0.05 MG/MG Topical OintmentSCD962b2e1a-ba9d-4b39-b6d1-2039471664825
197312acyclovir 5 % Topical OintmentSY962b2e1a-ba9d-4b39-b6d1-2039471664825
197312acyclovir 50 MG per 1 GM Topical OintmentSY962b2e1a-ba9d-4b39-b6d1-2039471664825
197312acycycloguanosine 0.05 MG/MG Topical OintmentSY962b2e1a-ba9d-4b39-b6d1-2039471664825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1360-1516721360011 TUBE in 1 CARTON (51672-1360-1) / 15 g in 1 TUBE1 tube2016-12-210000-00-00NoNoCurrent
51672-1360-2516721360021 TUBE in 1 CARTON (51672-1360-2) / 30 g in 1 TUBE1 tube2016-12-210000-00-00NoNoCurrent
51672-1360-5516721360051 TUBE in 1 CARTON (51672-1360-5) / 5 g in 1 TUBE1 tube2024-12-04NoNoCurrent