Home NDC 68180-202-03 SUPRAX
Product NDC 68180-202
Requested package NDC 68180-202-03
11-digit product format 681800202
Labeler code 68180
Product ID 68180-202_c1319364-40a7-4e77-a647-bf14c7256bc4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEFIXIME
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA065129
Marketing category ANDA
Marketing start 2004-03-01
Marketing end 0000-00-00
Substance CEFIXIME
Active strength 100 mg/5mL
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2024-12-31
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 · 12 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…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A065129-001 SUPRAX CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23
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 · 42 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 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL AB 2004-02-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL AB 2004-02-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL AB 2004-02-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL AB 2004-02-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065129-001 SUPRAX 100MG/5ML FOR SUSPENSION / ORAL 2004-02-23 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFIXIME ACTIVE INGREDIENT 97I1C92E55 SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 3 CEFIXIME ANHYDROUS ACTIVE MOIETY XZ7BG04GJX SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 3 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 3 STRAWBERRY INACTIVE INGREDIENT 4J2TY8Y81V SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 3 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 3
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CEFIXIME CEFIXIME Lupin Pharmaceuticals, Inc. 6d68dbd9-7d75-4ff1-91db-79ff8ae879ec 2025-10-14 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065129 application number: ANDA065129
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68180-202-03 68180020203 50 mL in 1 BOTTLE (68180-202-03) 50 ml 2004-03-01 0000-00-00 No No Current