Home NDC 70771-1371-2 acyclovir
Product NDC 70771-1371
Requested package NDC 70771-1371-2
11-digit product format 707711371
Labeler code 70771
Product ID 70771-1371_ed4f7f52-6254-46ad-8be4-e830705bbcfa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acyclovir
Dosage form OINTMENT
Route TOPICAL
Labeler Zydus Lifesciences Limited
Application ANDA205974
Marketing category ANDA
Marketing start 2019-03-21
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205974-001 ACYCLOVIR ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205974-001 AB
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205974-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2019-03-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 50 mg/g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197312 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 70771-1371-1 acyclovir 1 in 1 CARTON OINTMENT 1 4 70771-1371-1 acyclovir 15 g in 1 TUBE OINTMENT 15 4 70771-1371-2 acyclovir 30 g in 1 TUBE OINTMENT 30 4 70771-1371-2 acyclovir 1 in 1 CARTON OINTMENT 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1371 ACYCLOVIR OINTMENT [ZYDUS LIFESCIENCES LIMITED] 4 Current NDC, Legacy NDC, 4 package rows 20240817_fdf6b492-a76e-4cea-89a1-a5b19c7938ff.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.
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 70771-1371-2 70771137102 1 TUBE in 1 CARTON (70771-1371-2) / 30 g in 1 TUBE 1 tube 2019-03-21 0000-00-00 No No Current