Home NDC 25021-182-66 Cefuroxime sodium
Product NDC 25021-182
Requested package NDC 25021-182-66
11-digit product format 250210182
Labeler code 25021
Product ID 25021-182_3013653c-01f3-4ec7-a7fa-3e7b49adc4f0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefuroxime sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA064125
Marketing category ANDA
Marketing start 2016-09-01
Marketing end 0000-00-00
Substance CEFUROXIME SODIUM
Active strength 750 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2020-12-31
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 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A064125-001 CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 A064125-002 CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30
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 · 84 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 2026-08-18 06:07:40 2026-07 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 25021-182-66 25021018266 25 VIAL in 1 CARTON (25021-182-66) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 25 vial 2016-09-01 0000-00-00 No No Current