FDA.reportPublic FDA data

Acyclovir

Product NDC
70700-107
11-digit product format
707000107
Labeler code
70700
Product ID
70700-107_9ef6e425-efa1-aec8-223d-fc9a670767b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Xiromed, LLC
Application
ANDA201501
Marketing category
ANDA
Marketing start
2020-01-30
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201501-001ACYCLOVIRACYCLOVIR5%OINTMENT / TOPICALAB2020-01-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A201501-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A201501-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-01-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201501-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcyclovirACYCLOVIRBryant Ranch Prepacka4c15f29-313f-49ca-acfa-c0e6910f64fb2024-01-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201501
application number: ANDA201501
AcyclovirACYCLOVIRBryant Ranch Prepacke2b2c88a-84d2-42e6-ad18-819f7e78dbd62024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201501
application number: ANDA201501
AcyclovirACYCLOVIRBryant Ranch Prepackd04c696f-c072-46f7-9a92-9cbb476c827b2024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201501
application number: ANDA201501
AcyclovirACYCLOVIRXiromed, LLC3e222423-3bf2-6584-6d54-447b1b26dc422020-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201501
application number: ANDA201501
ndc (product): 70700-107

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X4HES1O11FInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197312Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e222423-3bf2-6584-6d54-447b1b26dc42Available on FDA.report

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
70700-107-15Acyclovir15 g in 1 TUBEOINTMENT159
70700-107-15Acyclovir1 in 1 CARTONOINTMENT19
70700-107-16Acyclovir1 in 1 CARTONOINTMENT19
70700-107-16Acyclovir30 g in 1 TUBEOINTMENT309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-107-15GM - Gram70700-1071459dada-6f42-4d18-8b6c-d180a196c00f12020-06-05
70700-107-16GM - Gram70700-107017b3129-14ee-4d7d-b3c9-e5ee112b7d1d12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-107ACYCLOVIR OINTMENT [XIROMED, LLC]9Current NDC, Legacy NDC, 4 package rows20230707_3e222423-3bf2-6584-6d54-447b1b26dc42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197312acyclovir 5 % Topical OintmentPSNe2b2c88a-84d2-42e6-ad18-819f7e78dbd6102
197312acyclovir 5 % Topical OintmentPSNd04c696f-c072-46f7-9a92-9cbb476c827b102
197312acyclovir 0.05 MG/MG Topical OintmentSCDe2b2c88a-84d2-42e6-ad18-819f7e78dbd6102
197312acyclovir 0.05 MG/MG Topical OintmentSCDd04c696f-c072-46f7-9a92-9cbb476c827b102
197312acyclovir 5 % Topical OintmentSYe2b2c88a-84d2-42e6-ad18-819f7e78dbd6102
197312acyclovir 5 % Topical OintmentSYd04c696f-c072-46f7-9a92-9cbb476c827b102
197312acyclovir 50 MG per 1 GM Topical OintmentSYe2b2c88a-84d2-42e6-ad18-819f7e78dbd6102
197312acyclovir 50 MG per 1 GM Topical OintmentSYd04c696f-c072-46f7-9a92-9cbb476c827b102
197312acycycloguanosine 0.05 MG/MG Topical OintmentSYd04c696f-c072-46f7-9a92-9cbb476c827b102
197312acycycloguanosine 0.05 MG/MG Topical OintmentSYe2b2c88a-84d2-42e6-ad18-819f7e78dbd6102
197312acyclovir 5 % Topical OintmentPSNa4c15f29-313f-49ca-acfa-c0e6910f64fb100
197312acyclovir 0.05 MG/MG Topical OintmentSCDa4c15f29-313f-49ca-acfa-c0e6910f64fb100
197312acyclovir 5 % Topical OintmentSYa4c15f29-313f-49ca-acfa-c0e6910f64fb100
197312acyclovir 50 MG per 1 GM Topical OintmentSYa4c15f29-313f-49ca-acfa-c0e6910f64fb100
197312acycycloguanosine 0.05 MG/MG Topical OintmentSYa4c15f29-313f-49ca-acfa-c0e6910f64fb100
197312acyclovir 5 % Topical OintmentPSN3e222423-3bf2-6584-6d54-447b1b26dc429
197312acyclovir 0.05 MG/MG Topical OintmentSCD3e222423-3bf2-6584-6d54-447b1b26dc429
197312acyclovir 5 % Topical OintmentSY3e222423-3bf2-6584-6d54-447b1b26dc429
197312acyclovir 50 MG per 1 GM Topical OintmentSY3e222423-3bf2-6584-6d54-447b1b26dc429
197312acycycloguanosine 0.05 MG/MG Topical OintmentSY3e222423-3bf2-6584-6d54-447b1b26dc429

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70700-107-15707000107151 TUBE in 1 CARTON (70700-107-15) / 15 g in 1 TUBE1 tube2020-01-300000-00-00NoNoCurrent
70700-107-16707000107161 TUBE in 1 CARTON (70700-107-16) / 30 g in 1 TUBE1 tube2020-01-300000-00-00NoNoCurrent