Acyclovir

Product NDC
69117-0039
11-digit product format
691170039
Labeler code
69117
Product ID
69117-0039_4728483c-da12-f257-e063-6294a90abe95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
YILING PHARMACEUTICAL, INC.
Application
ANDA212173
Marketing category
ANDA
Marketing start
2021-03-12
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

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
A212173-001ACYCLOVIRACYCLOVIR200MGCAPSULE / ORALAB2020-09-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212173-001AB

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
2026-02-19 14:30 UTC2026-02A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-144b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-14c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212173-001ACYCLOVIR200MGCAPSULE / ORALAB2020-09-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212173-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212173-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212173-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212173-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212173-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212173-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212173-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212173-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212173-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212173-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212173-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212173-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212173-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212173-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212173-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212173-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212173-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212173-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212173-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212173-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A212173-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212173-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212173-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212173-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212173-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212173-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212173-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212173-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212173-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212173-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A212173-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A212173-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212173-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212173-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212173-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212173-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212173-001AB1a50c72e98297…

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 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
197310Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8542495c-eef1-448b-abb5-83cb1ac589f7Available 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
69117-0039-1Acyclovir100 in 1 BOTTLECAPSULE1009
69117-0039-2Acyclovir500 in 1 BOTTLECAPSULE5009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69117-0039ACYCLOVIR CAPSULE [YILING PHARMACEUTICAL, INC.]8Current NDC, Legacy NDC, 2 package rows20250101_8542495c-eef1-448b-abb5-83cb1ac589f7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcyclovirACYCLOVIRAvet Pharmaceuticals Inc.4d5b5fd7-64ab-8275-e063-6394a90a22052026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212173
application number: ANDA212173
AcyclovirACYCLOVIRYILING PHARMACEUTICAL, INC.8542495c-eef1-448b-abb5-83cb1ac589f72025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212173
application number: ANDA212173
ndc (product): 69117-0039
AcyclovirACYCLOVIRChartwell RX, LLC8cd22728-34b4-4e55-8339-580138fe46d82025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212173
application number: ANDA212173

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN8542495c-eef1-448b-abb5-83cb1ac589f79
197310acyclovir 200 MG Oral CapsuleSCD8542495c-eef1-448b-abb5-83cb1ac589f79
197310acycycloguanosine 200 MG Oral CapsuleSY8542495c-eef1-448b-abb5-83cb1ac589f79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69117-0039-169117003901100 CAPSULE in 1 BOTTLE (69117-0039-1) 100 capsule2021-03-120000-00-00NoNoCurrent
69117-0039-269117003902500 CAPSULE in 1 BOTTLE (69117-0039-2) 500 capsule2021-03-120000-00-00NoNoCurrent