Acyclovir

Product NDC
69076-146
Requested package NDC
69076-146-01
11-digit product format
690760146
Labeler code
69076
Product ID
69076-146_f03d714d-ed3a-60fc-e053-2995a90a3153
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Quinn Pharmaceuticals
Application
ANDA075090
Marketing category
ANDA
Marketing start
2021-05-27
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
A075090-001ACYCLOVIRACYCLOVIR200MGCAPSULE / ORALAB1999-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075090-001AB

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 UTC2026-02A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-263f01610625f2…
2019-09-15 20:21 UTC2019-09A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075090-001ACYCLOVIR200MGCAPSULE / ORALAB1999-01-26cb3db0bc1861…

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 UTC2026-02A075090-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075090-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075090-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075090-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075090-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075090-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075090-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075090-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075090-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075090-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075090-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075090-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075090-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075090-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075090-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075090-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075090-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075090-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075090-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075090-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075090-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075090-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075090-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075090-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075090-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075090-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075090-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075090-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075090-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075090-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075090-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075090-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075090-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075090-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075090-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075090-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075090-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075090-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075090-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075090-001AB1cb3db0bc1861…

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
9ad711e4-003d-4b58-8177-32928bc42aa9Available 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
69076-146-01Acyclovir100 in 1 BOTTLECAPSULE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69076-146-01EA - Each69076-146f15830c4-4385-4048-9629-f9a162d0f7e212015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcyclovirACTIVE INGREDIENTX4HES1O11FACYCLOVIR CAPSULE [QUINN PHARMACEUTICALS, LLC]1
AcyclovirACTIVE MOIETYX4HES1O11FACYCLOVIR CAPSULE [QUINN PHARMACEUTICALS, LLC]1
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XACYCLOVIR CAPSULE [QUINN PHARMACEUTICALS, LLC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30ACYCLOVIR CAPSULE [QUINN PHARMACEUTICALS, LLC]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JACYCLOVIR CAPSULE [QUINN PHARMACEUTICALS, LLC]1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR CAPSULE [QUINN PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69076-146ACYCLOVIR CAPSULE [QUINN PHARMACEUTICALS]7Current NDC, Legacy NDC, 1 package rows20221221_9ad711e4-003d-4b58-8177-32928bc42aa9.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcyclovirACYCLOVIRFlorida Pharmaceutical Products, LLC3df7fa38-a869-45fb-98a3-81c5a2527d622026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075090
application number: ANDA075090
AcyclovirACYCLOVIRBryant Ranch Prepackf87c2c1e-568f-49e1-979e-fce80086fe082025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075090
application number: ANDA075090
AcyclovirACYCLOVIRA-S Medication Solutions6e813b35-4ead-42d6-bc51-9d7caf1db1ef2024-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075090
application number: ANDA075090
AcyclovirACYCLOVIRBryant Ranch Prepacke8433261-07f1-448b-aaf4-631414598c082023-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075090
application number: ANDA075090
AcyclovirACYCLOVIRQuinn Pharmaceuticals9ad711e4-003d-4b58-8177-32928bc42aa92022-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075090
application number: ANDA075090
ndc (package): 69076-146-01
ndc (product): 69076-146
ndc11 (package): 69076014601
AcyclovirACYCLOVIRProficient Rx LP6714cfd9-97d3-4290-b618-54594d89cf4e2020-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075090
application number: ANDA075090

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNe8433261-07f1-448b-aaf4-631414598c08100
197310acyclovir 200 MG Oral CapsuleSCDe8433261-07f1-448b-aaf4-631414598c08100
197310acycycloguanosine 200 MG Oral CapsuleSYe8433261-07f1-448b-aaf4-631414598c08100
197310acyclovir 200 MG Oral CapsulePSNf87c2c1e-568f-49e1-979e-fce80086fe0811
197310acyclovir 200 MG Oral CapsuleSCDf87c2c1e-568f-49e1-979e-fce80086fe0811
197310acycycloguanosine 200 MG Oral CapsuleSYf87c2c1e-568f-49e1-979e-fce80086fe0811
197310acyclovir 200 MG Oral CapsulePSN9ad711e4-003d-4b58-8177-32928bc42aa97
197310acyclovir 200 MG Oral CapsuleSCD9ad711e4-003d-4b58-8177-32928bc42aa97
197310acycycloguanosine 200 MG Oral CapsuleSY9ad711e4-003d-4b58-8177-32928bc42aa97
197310acyclovir 200 MG Oral CapsulePSN6e813b35-4ead-42d6-bc51-9d7caf1db1ef5
197310acyclovir 200 MG Oral CapsulePSN57eab132-77fc-4282-e053-2a91aa0a23275
197310acyclovir 200 MG Oral CapsuleSCD6e813b35-4ead-42d6-bc51-9d7caf1db1ef5
197310acyclovir 200 MG Oral CapsuleSCD57eab132-77fc-4282-e053-2a91aa0a23275
197310acycycloguanosine 200 MG Oral CapsuleSY6e813b35-4ead-42d6-bc51-9d7caf1db1ef5
197310acycycloguanosine 200 MG Oral CapsuleSY57eab132-77fc-4282-e053-2a91aa0a23275
197310acyclovir 200 MG Oral CapsulePSN6714cfd9-97d3-4290-b618-54594d89cf4e3
197310acyclovir 200 MG Oral CapsuleSCD6714cfd9-97d3-4290-b618-54594d89cf4e3
197310acycycloguanosine 200 MG Oral CapsuleSY6714cfd9-97d3-4290-b618-54594d89cf4e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69076-146-0169076014601100 CAPSULE in 1 BOTTLE (69076-146-01) 100 capsule2021-05-270000-00-00NoNoCurrent