Home NDC 55150-154 Acyclovir Sodium
Product NDC 55150-154
11-digit product format 551500154
Labeler code 55150
Product ID 55150-154_410e306b-e8b9-4ff5-b703-a3005eec272f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir Sodium
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application ANDA203701
Marketing category ANDA
Marketing start 2013-10-11
Substance ACYCLOVIR SODIUM
Active strength 500 mg/10mL
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 A203701-001 ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203701-001 AP
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 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 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 Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACYCLOVIR SODIUM 500 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 927L42J563 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1734932 Internal RxNorm lookup 1734934 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 55150-154-10 Acyclovir Sodium 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 7 55150-154-10 Acyclovir Sodium 10 in 1 CARTON INJECTION, SOLUTION 10 7 55150-154-11 Acyclovir Sodium 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 2 55150-154-11 Acyclovir Sodium 10 in 1 CARTON INJECTION, SOLUTION 10 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-154 ACYCLOVIR SODIUM INJECTION, SOLUTION [EUGIA US LLC] 7 Current NDC, Legacy NDC, 2 package rows 20230707_ae921e4e-b8ae-4a45-acc1-32e5e719812b.zip 55150-154 ACYCLOVIR SODIUM INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] 2 Current NDC, Legacy NDC, 2 package rows 20181114_d3ab226c-677d-4cb7-85cb-1c2e5012f40d.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55150-154-10 55150015410 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-154-10) / 10 mL in 1 VIAL, SINGLE-DOSE 2013-10-11 0000-00-00 No No Current 55150-154-11 55150015411 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-154-11) / 10 mL in 1 VIAL, SINGLE-DOSE 2013-10-11 0000-00-00 No No Current