Home NDC 71209-005 Acyclovir
Product NDC 71209-005
11-digit product format 712090005
Labeler code 71209
Product ID 71209-005_4c64f761-cab6-4360-9561-89b32c3ec030
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form TABLET
Route ORAL
Labeler Cadila Pharmaceuticals Limited
Application ANDA202168
Marketing category ANDA
Marketing start 2017-03-23
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 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202168-001 ACYCLOVIR ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 A202168-002 ACYCLOVIR ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Acyclovir
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACYCLOVIR 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X4HES1O11F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197311 Internal RxNorm lookup 197313 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71209-005-05 Acyclovir 100 in 1 BOTTLE TABLET 100 6 71209-005-10 Acyclovir 500 in 1 BOTTLE TABLET 500 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71209-005 ACYCLOVIR TABLET [CADILA PHARMACEUTICALS LIMITED] 5 Current NDC, Legacy NDC, 2 package rows 20221231_acef88f4-6456-4092-993f-27e1496097c7.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71209-005-05 71209000505 100 TABLET in 1 BOTTLE (71209-005-05) 100 tablet 2018-11-20 0000-00-00 No No Current 71209-005-10 71209000510 500 TABLET in 1 BOTTLE (71209-005-10) 500 tablet 2018-11-20 0000-00-00 No No Current