acyclovir

Product NDC
70771-1082
11-digit product format
707711082
Labeler code
70771
Product ID
70771-1082_6d339b2f-84ca-4174-8774-cbc1b9cec98a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Zydus Lifesciences Limited
Application
ANDA206606
Marketing category
ANDA
Marketing start
2017-08-17
Marketing end
0000-00-00
Substance
ACYCLOVIR SODIUM
Active strength
1000 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
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70771-1082DDiscontinued by firm2026-08-17
excluded packagepackage70771-108270771-1082-6DDiscontinued by firm2026-08-17

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 · 4 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 packagepackage70771-1082-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70771-1082-6f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A206606-001ACYCLOVIR SODIUMACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-13
A206606-002ACYCLOVIR SODIUMACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-13

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206606-001ACYCLOVIR SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2017-06-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206606-002ACYCLOVIR SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2017-06-13bb7c543d1eb4…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1082ACYCLOVIR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS LIFESCIENCES LIMITED]4Legacy NDC20221019_3564bff9-794c-4e5d-aead-a1bf3de18ecb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1082-67077110820610 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (70771-1082-6) 2017-08-170000-00-00NoNoCurrent