Acyclovir

Product NDC
31722-968
11-digit product format
317220968
Labeler code
31722
Product ID
31722-968_8a7294a3-588a-4ae1-baaa-4a4402ee3bad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA212495
Marketing category
ANDA
Marketing start
2020-09-01
Marketing end
0000-00-00
Substance
ACYCLOVIR
Active strength
50 mg/g
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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct31722-968IInactivated by FDA2026-09-14
excluded packagepackage31722-96831722-968-31IInactivated by FDA2026-09-14
excluded packagepackage31722-96831722-968-32IInactivated by FDA2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 54 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage31722-968-31d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage31722-968-32d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage31722-968-31f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage31722-968-32f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage31722-968-312ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage31722-968-322ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage31722-968-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage31722-968-32a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage31722-968-31cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage31722-968-32cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage31722-968-31cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage31722-968-32cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage31722-968-31302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage31722-968-32302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage31722-968-31ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage31722-968-32ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage31722-968-310efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage31722-968-320efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage31722-968-31ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage31722-968-32ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage31722-968-31367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage31722-968-32367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage31722-968-31557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage31722-968-32557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage31722-968-318af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage31722-968-328af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage31722-968-31834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage31722-968-32834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage31722-968-311332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage31722-968-321332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage31722-968-31fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage31722-968-32fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage31722-968-3186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage31722-968-3286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage31722-968-31bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage31722-968-32bd6a592717d7…303034d00443…

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
A212495-001ACYCLOVIRACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212495-001AB

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
2026-09-14 22:38:342026-08A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-0784e616aacf4f…
2026-08-18 06:07:402026-07A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-074b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212495-001ACYCLOVIR5%OINTMENT / TOPICALAB2020-04-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A212495-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A212495-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212495-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212495-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212495-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212495-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212495-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212495-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212495-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212495-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212495-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212495-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212495-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212495-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212495-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212495-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212495-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212495-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212495-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212495-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212495-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212495-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A212495-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212495-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212495-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212495-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212495-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212495-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212495-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212495-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212495-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212495-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A212495-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A212495-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212495-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212495-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212495-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212495-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212495-001AB1a50c72e98297…

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
31722-968-31Acyclovir15 g in 1 TUBEOINTMENT153
31722-968-31Acyclovir1 in 1 CARTONOINTMENT13
31722-968-32Acyclovir30 g in 1 TUBEOINTMENT303
31722-968-32Acyclovir1 in 1 CARTONOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-968ACYCLOVIR OINTMENT [CAMBER PHARMACEUTICALS, INC.]3Legacy NDC, 4 package rows20200901_bedf63da-6301-4643-9ac5-fe63eea57215.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197312acyclovir 5 % Topical OintmentPSNbedf63da-6301-4643-9ac5-fe63eea572153
197312acyclovir 0.05 MG/MG Topical OintmentSCDbedf63da-6301-4643-9ac5-fe63eea572153
197312acyclovir 5 % Topical OintmentSYbedf63da-6301-4643-9ac5-fe63eea572153
197312acyclovir 50 MG per 1 GM Topical OintmentSYbedf63da-6301-4643-9ac5-fe63eea572153
197312acycycloguanosine 0.05 MG/MG Topical OintmentSYbedf63da-6301-4643-9ac5-fe63eea572153

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-968-31317220968311 TUBE in 1 CARTON (31722-968-31) > 15 g in 1 TUBE1 tube2020-09-010000-00-00NoNoCurrent
31722-968-32317220968321 TUBE in 1 CARTON (31722-968-32) > 30 g in 1 TUBE1 tube2020-09-010000-00-00NoNoCurrent