Home NDC 71335-0470 ACYCLOVIR
Product NDC 71335-0470
11-digit product format 713350470
Labeler code 71335
Product ID 71335-0470_1848497f-16ba-4911-b27f-a4b5e645767f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ACYCLOVIR
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA075677
Marketing category ANDA
Marketing start 2006-03-20
Marketing end 2027-04-30
Substance ACYCLOVIR
Active strength 200 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
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075677-001 ACYCLOVIR ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075677-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075677-001 ACYCLOVIR 200MG CAPSULE / ORAL AB RS 2005-09-28 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ACYCLOVIR Active Ingredients# Ingredient, Strength table Ingredient Strength ACYCLOVIR 200 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197310 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0470 ACYCLOVIR CAPSULE [BRYANT RANCH PREPACK] 6 Current NDC, Legacy NDC, 10 package rows 20240724_2b600b5d-ce91-461f-b9d1-75b969daf8e9.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 71335-0470-0 71335047000 90 CAPSULE in 1 BOTTLE (71335-0470-0) 90 capsule 2024-07-09 2027-04-30 No No Current 71335-0470-1 71335047001 30 CAPSULE in 1 BOTTLE (71335-0470-1) 30 capsule 2019-07-11 2027-04-30 No No Current 71335-0470-2 71335047002 25 CAPSULE in 1 BOTTLE (71335-0470-2) 25 capsule 2018-03-28 2027-04-30 No No Current 71335-0470-3 71335047003 35 CAPSULE in 1 BOTTLE (71335-0470-3) 35 capsule 2018-06-22 2027-04-30 No No Current 71335-0470-4 71335047004 50 CAPSULE in 1 BOTTLE (71335-0470-4) 50 capsule 2024-07-09 2027-04-30 No No Current 71335-0470-5 71335047005 100 CAPSULE in 1 BOTTLE (71335-0470-5) 100 capsule 2024-07-09 2027-04-30 No No Current 71335-0470-6 71335047006 40 CAPSULE in 1 BOTTLE (71335-0470-6) 40 capsule 2024-07-09 2027-04-30 No No Current 71335-0470-7 71335047007 60 CAPSULE in 1 BOTTLE (71335-0470-7) 60 capsule 2019-01-04 2027-04-30 No No Current 71335-0470-8 71335047008 120 CAPSULE in 1 BOTTLE (71335-0470-8) 120 capsule 2024-07-09 2027-04-30 No No Current 71335-0470-9 71335047009 20 CAPSULE in 1 BOTTLE (71335-0470-9) 20 capsule 2024-07-09 2027-04-30 No No Current