ACYCLOVIR

Product NDC
72162-1704
11-digit product format
721621704
Labeler code
72162
Product ID
72162-1704_8e0f975a-31f6-4be4-81a5-a7e42b4f5262
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075677
Marketing category
ANDA
Marketing start
2006-03-20
Marketing end
2027-04-30
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
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075677-001ACYCLOVIRACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075677-001AB

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-2884e616aacf4f…
2026-08-18 06:07:402026-07A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-283f01610625f2…
2019-09-15 20:21 UTC2019-09A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075677-001ACYCLOVIR200MGCAPSULE / ORALABRS2005-09-28f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A075677-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A075677-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075677-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075677-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075677-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075677-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075677-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075677-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075677-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075677-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075677-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075677-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075677-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075677-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075677-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075677-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075677-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075677-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075677-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075677-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075677-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075677-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075677-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075677-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075677-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075677-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075677-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075677-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075677-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075677-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075677-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075677-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075677-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075677-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075677-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075677-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075677-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075677-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075677-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075677-001AB1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
ACYCLOVIR

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
e5356160-cb35-4ff6-91d5-2ade594e0279Available 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
72162-1704-0ACYCLOVIR120 in 1 BOTTLECAPSULE120102
72162-1704-1ACYCLOVIR100 in 1 BOTTLECAPSULE100102
72162-1704-2ACYCLOVIR25 in 1 BOTTLECAPSULE25102
72162-1704-3ACYCLOVIR30 in 1 BOTTLECAPSULE30102
72162-1704-4ACYCLOVIR35 in 1 BOTTLECAPSULE35102
72162-1704-5ACYCLOVIR20 in 1 BOTTLECAPSULE20102
72162-1704-6ACYCLOVIR60 in 1 BOTTLECAPSULE60102
72162-1704-7ACYCLOVIR50 in 1 BOTTLECAPSULE50102
72162-1704-8ACYCLOVIR40 in 1 BOTTLECAPSULE40102
72162-1704-9ACYCLOVIR90 in 1 BOTTLECAPSULE90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1704-0EA - Each72162-170496a4b84a-76dd-4acb-8423-f493730cb7f612023-10-16
72162-1704-1EA - Each72162-17046d5b413e-529f-4d56-85da-e585b958aecb12023-10-16
72162-1704-2EA - Each72162-1704550ce522-311a-4d9a-8bdf-5cd99010e5a012023-10-16
72162-1704-3EA - Each72162-1704c8a721dc-4e90-4a80-8919-7c1c00414d1712023-10-16
72162-1704-4EA - Each72162-17046c235f07-6672-4143-abf8-25dfcfe8b3b512023-10-16
72162-1704-5EA - Each72162-170466fe74bb-a1cc-4f96-b873-136066a5153f12023-10-16
72162-1704-6EA - Each72162-1704351b86d2-5577-4441-bdbe-2dd7cf1065c612023-10-16
72162-1704-7EA - Each72162-17048e579939-504c-481c-9fe5-2448d646bc5f12023-10-16
72162-1704-8EA - Each72162-17044a795a48-9f1e-403d-b630-221e6165a7c012023-10-16
72162-1704-9EA - Each72162-1704d30210c8-1c18-4f73-8c0a-b23b3da461e112023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1704ACYCLOVIR CAPSULE [BRYANT RANCH PREPACK]101Current NDC, 10 package rows20240730_e5356160-cb35-4ff6-91d5-2ade594e0279.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACYCLOVIRACYCLOVIRBryant Ranch Prepack2b600b5d-ce91-461f-b9d1-75b969daf8e92026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075677
application number: ANDA075677
ACYCLOVIRACYCLOVIRBryant Ranch Prepacke5356160-cb35-4ff6-91d5-2ade594e02792026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075677
application number: ANDA075677
ndc (product): 72162-1704
ACYCLOVIRACYCLOVIRApotex Corp.41bea43a-f58c-2c6f-4d31-406ceb4560772025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075677
application number: ANDA075677
ACYCLOVIRACYCLOVIRProficient Rx LP8d7994a6-5bd2-494d-89c1-b03755d4f2c32020-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075677
application number: ANDA075677

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNe5356160-cb35-4ff6-91d5-2ade594e0279102
197310acyclovir 200 MG Oral CapsuleSCDe5356160-cb35-4ff6-91d5-2ade594e0279102
197310acycycloguanosine 200 MG Oral CapsuleSYe5356160-cb35-4ff6-91d5-2ade594e0279102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72162-1704-072162170400120 CAPSULE in 1 BOTTLE (72162-1704-0) 120 capsule2026-03-252027-04-30NoNoHistorical
72162-1704-172162170401100 CAPSULE in 1 BOTTLE (72162-1704-1) 100 capsule2026-03-252027-04-30NoNoHistorical
72162-1704-27216217040225 CAPSULE in 1 BOTTLE (72162-1704-2) 25 capsule2026-03-252027-04-30NoNoHistorical
72162-1704-37216217040330 CAPSULE in 1 BOTTLE (72162-1704-3) 30 capsule2026-03-252027-04-30NoNoHistorical
72162-1704-47216217040435 CAPSULE in 1 BOTTLE (72162-1704-4) 35 capsule2026-03-252027-04-30NoNoHistorical
72162-1704-57216217040520 CAPSULE in 1 BOTTLE (72162-1704-5) 20 capsule2026-03-252027-04-30NoNoHistorical
72162-1704-67216217040660 CAPSULE in 1 BOTTLE (72162-1704-6) 60 capsule2026-03-252027-04-30NoNoHistorical
72162-1704-77216217040750 CAPSULE in 1 BOTTLE (72162-1704-7) 50 capsule2026-03-252027-04-30NoNoHistorical
72162-1704-87216217040840 CAPSULE in 1 BOTTLE (72162-1704-8) 40 capsule2026-03-252027-04-30NoNoHistorical
72162-1704-97216217040990 CAPSULE in 1 BOTTLE (72162-1704-9) 90 capsule2026-03-252027-04-30NoNoHistorical