ACYCLOVIR

Product NDC
23155-229
11-digit product format
231550229
Labeler code
23155
Product ID
23155-229_36122e1a-0925-448e-8fae-253b60c49a6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA074889
Marketing category
ANDA
Marketing start
2014-06-02
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

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
A074889-001ACYCLOVIRACYCLOVIR200MGCAPSULE / ORALAB1997-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074889-001AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-313f01610625f2…
2019-09-15 20:21 UTC2019-09A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074889-001ACYCLOVIR200MGCAPSULE / ORALAB1997-10-31cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074889-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074889-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074889-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074889-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074889-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074889-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074889-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074889-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074889-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074889-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074889-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074889-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074889-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074889-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074889-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074889-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074889-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074889-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074889-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074889-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074889-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074889-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074889-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074889-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074889-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074889-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074889-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074889-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074889-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074889-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074889-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074889-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074889-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074889-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074889-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074889-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074889-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074889-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074889-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074889-001AB1cb3db0bc1861…

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 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
85332671-0e3a-4445-a337-e1266886b9cfAvailable 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
23155-229-01ACYCLOVIR100 in 1 BOTTLECAPSULE1007
23155-229-05ACYCLOVIR500 in 1 BOTTLECAPSULE5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-229-01EA - Each23155-229435aa9f1-04d2-4b91-ad72-e14cd6e9485312018-06-11
23155-229-05EA - Each23155-229a5f6f32c-df98-44fe-a326-a085fed9a49512018-06-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
GELATININACTIVE INGREDIENT2G86QN327LACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35ACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-229ACYCLOVIR CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 2 package rows20230727_85332671-0e3a-4445-a337-e1266886b9cf.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
ACYCLOVIRACYCLOVIRMajor Pharmaceuticals9b254eed-8ea1-469b-bf27-f5670cd99e8d2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074889
application number: ANDA074889
ACYCLOVIRACYCLOVIRHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.85332671-0e3a-4445-a337-e1266886b9cf2026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074889
application number: ANDA074889
ndc (product): 23155-229
ACYCLOVIRACYCLOVIRCardinal Health 107, LLC4cc7d67f-35fa-4238-a581-4810645083cf2026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074889
application number: ANDA074889

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN85332671-0e3a-4445-a337-e1266886b9cf7
197310acyclovir 200 MG Oral CapsuleSCD85332671-0e3a-4445-a337-e1266886b9cf7
197310acycycloguanosine 200 MG Oral CapsuleSY85332671-0e3a-4445-a337-e1266886b9cf7
197310acyclovir 200 MG Oral CapsulePSN9b254eed-8ea1-469b-bf27-f5670cd99e8d2
197310acyclovir 200 MG Oral CapsuleSCD9b254eed-8ea1-469b-bf27-f5670cd99e8d2
197310acycycloguanosine 200 MG Oral CapsuleSY9b254eed-8ea1-469b-bf27-f5670cd99e8d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-229-0123155022901100 CAPSULE in 1 BOTTLE (23155-229-01) 100 capsule2014-06-020000-00-00NoNoCurrent
23155-229-0523155022905500 CAPSULE in 1 BOTTLE (23155-229-05) 500 capsule2014-06-020000-00-00NoNoCurrent