FDA.reportPublic FDA data

Acyclovir

Product NDC
21695-009
11-digit product format
216950009
Labeler code
21695
Product ID
21695-009_a2db7131-bf31-47bf-bf61-594f919af1f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA074975
Marketing category
ANDA
Marketing start
1998-10-30
Marketing end
0000-00-00
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
21695-009-252019-09-24C16284748780-1934fe258-4cce-48b1-e053-8cdaa90a720aAcyclovir
21695-009-302019-09-24C16284748780-1934fe258-4cce-48b1-e053-8cdaa90a720aAcyclovir

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-009-25Acyclovir25 in 1 BOTTLECAPSULE251
21695-009-30Acyclovir30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-009-25EA - Each21695-0093ef5b1ce-857d-4da1-b149-6151ea65f70912012-07-24
21695-009-30EA - Each21695-0091dd5ebc6-20cf-421c-ba3a-648c0972e1f912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcyclovirACTIVE INGREDIENTX4HES1O11FACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
acyclovirACTIVE MOIETYX4HES1O11FACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
gelatinINACTIVE INGREDIENT2G86QN327LACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-009ACYCLOVIR CAPSULE ACYCLOVIR TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110121_a2db7131-bf31-47bf-bf61-594f919af1f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNa2db7131-bf31-47bf-bf61-594f919af1f21
197311acyclovir 400 MG Oral TabletPSNa2db7131-bf31-47bf-bf61-594f919af1f21
197313acyclovir 800 MG Oral TabletPSNa2db7131-bf31-47bf-bf61-594f919af1f21
197310acyclovir 200 MG Oral CapsuleSCDa2db7131-bf31-47bf-bf61-594f919af1f21
197311acyclovir 400 MG Oral TabletSCDa2db7131-bf31-47bf-bf61-594f919af1f21
197313acyclovir 800 MG Oral TabletSCDa2db7131-bf31-47bf-bf61-594f919af1f21
197310acycycloguanosine 200 MG Oral CapsuleSYa2db7131-bf31-47bf-bf61-594f919af1f21
197311acycycloguanosine 400 MG Oral TabletSYa2db7131-bf31-47bf-bf61-594f919af1f21
197313acycycloguanosine 800 MG Oral TabletSYa2db7131-bf31-47bf-bf61-594f919af1f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-009-252169500092525 in 1 BOTTLEHistorical
21695-009-302169500093030 in 1 BOTTLEHistorical