Home NDC 43063-589 Acyclovir
Product NDC 43063-589
11-digit product format 430630589
Labeler code 43063
Product ID 43063-589_509f352e-407a-d52b-e063-6294a90a696a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA203834
Marketing category ANDA
Marketing start 2013-11-29
Substance ACYCLOVIR
Active strength 800 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A203834-001 ACYCLOVIR ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 A203834-002 ACYCLOVIR ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29
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 · 88 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 2026-10-15 13:18:30 2026-09 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Acyclovir
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACYCLOVIR 800 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 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 43063-589-10 Acyclovir 10 in 1 BOTTLE, PLASTIC TABLET 10 17 43063-589-30 Acyclovir 30 in 1 BOTTLE, PLASTIC TABLET 30 17 43063-589-35 Acyclovir 35 in 1 BOTTLE, PLASTIC TABLET 35 17 43063-589-50 Acyclovir 50 in 1 BOTTLE, PLASTIC TABLET 50 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACYCLOVIR ACTIVE INGREDIENT X4HES1O11F ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 4 ACYCLOVIR ACTIVE MOIETY X4HES1O11F ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 4 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 4 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 4 POVIDONE INACTIVE INGREDIENT FZ989GH94E ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-589 ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] 15 Current NDC, Legacy NDC, 4 package rows 20241013_e8a0f9f8-294f-4dd6-bd55-10a6253f1aa8.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 2 of 2 · 22 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 43063-589-10 43063058910 10 TABLET in 1 BOTTLE, PLASTIC (43063-589-10) 10 tablet 2016-08-04 0000-00-00 No No Current 43063-589-30 43063058930 30 TABLET in 1 BOTTLE, PLASTIC (43063-589-30) 30 tablet 2015-09-29 0000-00-00 No No Current 43063-589-35 43063058935 35 TABLET in 1 BOTTLE, PLASTIC (43063-589-35) 35 tablet 2015-08-06 0000-00-00 No No Current 43063-589-50 43063058950 50 TABLET in 1 BOTTLE, PLASTIC (43063-589-50) 50 tablet 2015-09-11 0000-00-00 No No Current