Home NDC 10544-102 Acyclovir
Product NDC 10544-102
11-digit product format 105440102
Labeler code 10544
Product ID 10544-102_1217cc75-15cd-4c1b-8147-125d7db61bd7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form TABLET
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA074556
Marketing category ANDA
Marketing start 2010-03-11
Marketing end 0000-00-00
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 E
Listing certified through 2017-12-31
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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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date A074556-001 ACYCLOVIR ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 A074556-002 ACYCLOVIR ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 A074556-003 ACYCLOVIR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 · 132 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 A074556-001 ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A074556-002 ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A074556-003 ACYCLOVIR 800MG TABLET / ORAL AB 1997-04-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 A074556-001 ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074556-002 ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074556-003 ACYCLOVIR 800MG TABLET / ORAL AB 1997-04-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074556-001 ACYCLOVIR 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1997-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074556-002 ACYCLOVIR 400MG TABLET / ORAL AB 1997-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074556-003 ACYCLOVIR 800MG TABLET / ORAL AB 1997-04-22 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10544-102-25 Acyclovir 25 in 1 BOTTLE TABLET 25 2 10544-102-40 Acyclovir 40 in 1 BOTTLE TABLET 40 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACYCLOVIR ACTIVE INGREDIENT X4HES1O11F ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 2 ACYCLOVIR ACTIVE MOIETY X4HES1O11F ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-102 ACYCLOVIR TABLET [BLENHEIM PHARMACAL, INC.] 2 Legacy NDC, 2 package rows 20110429_c48d04a4-e8ca-4948-a2ff-b45ea44b49b0.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-102-25 10544010225 25 in 1 BOTTLE Historical 10544-102-40 10544010240 40 in 1 BOTTLE Historical