ACYCLOVIR

Product NDC
61919-370
11-digit product format
619190370
Labeler code
61919
Product ID
61919-370_f2134011-7f6b-7b13-e053-2a95a90a5199
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
TABLET
Route
ORAL
Labeler
Direct RX
Application
ANDA075382
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
ACYCLOVIR
Active strength
400 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
2024-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-370IInactivated by FDA2026-08-10
excluded packagepackage61919-37061919-370-14IInactivated by FDA2026-08-10
excluded packagepackage61919-37061919-370-30IInactivated by FDA2026-08-10
excluded packagepackage61919-37061919-370-40IInactivated by FDA2026-08-10

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 · 39 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-370-14IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-370-40IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-370-30IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-370-14IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-370-40IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-370-30IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-370-14IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-370-40IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-370-30IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-370-14IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-370-40IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-370-30IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-370-14IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-370-40IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-370-30IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-370-14IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-370-40IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-370-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-370-40UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-370-30UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-370-14UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-370-40UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-370-30UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-370-14UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-370-40UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-370-30UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-370-14UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61919-370-30EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61919-370-40EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075382-001ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB1999-04-30
A075382-002ACYCLOVIRACYCLOVIR800MGTABLET / ORALAB1999-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075382-001AB
A075382-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075382-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075382-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075382-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075382-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075382-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075382-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075382-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075382-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075382-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075382-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075382-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075382-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075382-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075382-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075382-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075382-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075382-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075382-002AB1782e0a99824c…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-370-142025-01-30C16284748780-12cef2736-a91b-d83d-e063-dadaa90ab31fACYCLOVIR
61919-370-302025-01-30C16284748780-12cef2736-a91b-d83d-e063-dadaa90ab31fACYCLOVIR
61919-370-402025-01-30C16284748780-12cef2736-a91b-d83d-e063-dadaa90ab31fACYCLOVIR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-370-14ACYCLOVIR14 in 1 BOTTLETABLET149
61919-370-30ACYCLOVIR30 in 1 BOTTLETABLET309
61919-370-40ACYCLOVIR40 in 1 BOTTLETABLET409

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-370-30EA - Each61919-37034f9d748-6304-4bea-9489-bf2dcc44f2d212015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [DIRECT RX]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-370ACYCLOVIR TABLET [DIRECT RX]9Legacy NDC, 3 package rows20230421_5f95a4f4-4822-4502-afbf-b592cafc1ae9.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcyclovirACYCLOVIRCardinal Health 107, LLCd8004652-86fe-4714-81d4-5e1dd2585bb42026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.c2d9940a-ce88-5fd0-e053-2a95a90a4bc82026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRAvPAK6e203fa9-ee97-1e08-8d6a-fb57cfa13e192026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepackf3cbd634-77c8-3306-bdbd-a4598b20603e2024-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepacke0f17e6f-63c7-4828-8585-91fc582df30b2024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepackf09cdb3f-dfd2-4e47-bb5e-a5d26d8bcc892024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepack8c5d1f30-2d31-417d-860b-7228b7baaa642024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRGolden State Medical Supply, Inc.785d68bc-0bbf-b69d-e053-2991aa0ac0d52024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepack89583890-186b-4a7a-8741-41f6c5f0a99d2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRCarlsbad Technology, Inc.a68e610a-841c-4b69-9233-673d060561e82024-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.c46d5033-b1b2-e213-e053-2995a90ae6a32024-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRProficient Rx LP33630a35-346e-43b6-9286-89e28ac0094a2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN5f95a4f4-4822-4502-afbf-b592cafc1ae99
197311acyclovir 400 MG Oral TabletSCD5f95a4f4-4822-4502-afbf-b592cafc1ae99
197311acycycloguanosine 400 MG Oral TabletSY5f95a4f4-4822-4502-afbf-b592cafc1ae99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-370-146191903701414 TABLET in 1 BOTTLE (61919-370-14) 14 tablet2014-01-010000-00-00NoNoCurrent
61919-370-306191903703030 TABLET in 1 BOTTLE (61919-370-30) 30 tablet2014-01-010000-00-00NoNoCurrent
61919-370-406191903704040 TABLET in 1 BOTTLE (61919-370-40) 40 tablet2015-01-010000-00-00NoNoCurrent