Acyclovir

Product NDC
50090-5610
11-digit product format
500905610
Labeler code
50090
Product ID
50090-5610_a6cc5d9a-f1aa-4ca0-b3de-c7ee13eb9d86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
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
6e813b35-4ead-42d6-bc51-9d7caf1db1efAvailable 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5610-0Acyclovir25 in 1 BOTTLECAPSULE255
50090-5610-1Acyclovir50 in 1 BOTTLECAPSULE505
50090-5610-7Acyclovir30 in 1 BOTTLECAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5610-0EA - Each50090-5610101f6e24-e519-4d41-9c67-cceae5e0527712022-12-07
50090-5610-1EA - Each50090-561072a96334-32a0-42b2-a4ff-10588e3ca5d212022-12-07
50090-5610-7EA - Each50090-5610a4a38d0d-d964-4bc5-9eb8-6fa58d1b23cd12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5610ACYCLOVIR CAPSULE [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 3 package rows20240214_6e813b35-4ead-42d6-bc51-9d7caf1db1ef.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
ndc (product): 50090-5610
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
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 CapsulePSN6e813b35-4ead-42d6-bc51-9d7caf1db1ef5
197310acyclovir 200 MG Oral CapsuleSCD6e813b35-4ead-42d6-bc51-9d7caf1db1ef5
197310acycycloguanosine 200 MG Oral CapsuleSY6e813b35-4ead-42d6-bc51-9d7caf1db1ef5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5610-05009056100025 CAPSULE in 1 BOTTLE (50090-5610-0) 25 capsule2021-08-050000-00-00NoNoCurrent
50090-5610-15009056100150 CAPSULE in 1 BOTTLE (50090-5610-1) 50 capsule2021-08-050000-00-00NoNoCurrent
50090-5610-75009056100730 CAPSULE in 1 BOTTLE (50090-5610-7) 30 capsule2021-08-050000-00-00NoNoCurrent