Home NDC 0093-8947 Acyclovir
Product NDC 0093-8947
11-digit product format 000938947
Labeler code 0093
Product ID 0093-8947_e04881cc-2a17-41a2-a89d-2ab1df0d2abd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA074556
Marketing category ANDA
Marketing start 1997-04-30
Marketing end 2020-01-31
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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074556-001 ACYCLOVIR ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 A074556-002 ACYCLOVIR ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 A074556-003 ACYCLOVIR ACYCLOVIR 800MG TABLET / ORAL AB 1997-04-22
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 4 · 123 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 A074556-001 ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074556-002 ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074556-003 ACYCLOVIR 800MG TABLET / ORAL AB 1997-04-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074556-001 ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074556-002 ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074556-003 ACYCLOVIR 800MG TABLET / ORAL AB 1997-04-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074556-001 ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074556-002 ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074556-003 ACYCLOVIR 800MG TABLET / ORAL AB 1997-04-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074556-001 ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074556-002 ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074556-003 ACYCLOVIR 800MG TABLET / ORAL AB 1997-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074556-001 ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074556-002 ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074556-003 ACYCLOVIR 800MG TABLET / ORAL AB 1997-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074556-001 ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074556-002 ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074556-003 ACYCLOVIR 800MG TABLET / ORAL AB 1997-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074556-001 ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074556-002 ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074556-003 ACYCLOVIR 800MG TABLET / ORAL AB 1997-04-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074556-001 ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074556-002 ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074556-003 ACYCLOVIR 800MG TABLET / ORAL AB 1997-04-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074556-001 ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074556-002 ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074556-003 ACYCLOVIR 800MG TABLET / ORAL AB 1997-04-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074556-001 ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074556-002 ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074556-003 ACYCLOVIR 800MG TABLET / ORAL AB 1997-04-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074556-001 ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074556-002 ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074556-003 ACYCLOVIR 800MG TABLET / ORAL AB 1997-04-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074556-001 ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074556-002 ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074556-003 ACYCLOVIR 800MG TABLET / ORAL AB 1997-04-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074556-001 ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074556-002 ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074556-003 ACYCLOVIR 800MG TABLET / ORAL AB 1997-04-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074556-001 ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACYCLOVIR ACTIVE INGREDIENT X4HES1O11F ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 ACYCLOVIR ACTIVE MOIETY X4HES1O11F ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 GELATIN INACTIVE INGREDIENT 2G86QN327L ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 POVIDONE K25 INACTIVE INGREDIENT K0KQV10C35 ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACYCLOVIR CAPSULE ACYCLOVIR TABLET [TEVA PHARMACEUTICALS USA INC] 14 ACYCLOVIR ACTIVE INGREDIENT X4HES1O11F ACYCLOVIR TABLET [CLINICAL SOLUTIONS WHOLESALE] 8 ACYCLOVIR ACTIVE MOIETY X4HES1O11F ACYCLOVIR TABLET [CLINICAL SOLUTIONS WHOLESALE] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACYCLOVIR TABLET [CLINICAL SOLUTIONS WHOLESALE] 8 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ACYCLOVIR TABLET [CLINICAL SOLUTIONS WHOLESALE] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ACYCLOVIR TABLET [CLINICAL SOLUTIONS WHOLESALE] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACYCLOVIR TABLET [CLINICAL SOLUTIONS WHOLESALE] 8 POVIDONES INACTIVE INGREDIENT FZ989GH94E ACYCLOVIR TABLET [CLINICAL SOLUTIONS WHOLESALE] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ACYCLOVIR TABLET [CLINICAL SOLUTIONS WHOLESALE] 8 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ACYCLOVIR TABLET [CLINICAL SOLUTIONS WHOLESALE] 8 ACYCLOVIR ACTIVE INGREDIENT X4HES1O11F ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 3 ACYCLOVIR ACTIVE INGREDIENT X4HES1O11F ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 ACYCLOVIR ACTIVE MOIETY X4HES1O11F ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 3 ACYCLOVIR ACTIVE MOIETY X4HES1O11F ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 3 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC] 3 ACYCLOVIR ACTIVE INGREDIENT X4HES1O11F ACYCLOVIR TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ACYCLOVIR ACTIVE MOIETY X4HES1O11F ACYCLOVIR TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACYCLOVIR TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ACYCLOVIR TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ACYCLOVIR TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACYCLOVIR TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E ACYCLOVIR TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ACYCLOVIR TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ACYCLOVIR TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed RxNorm Mappings#