Home NDC 68180-416 CEFIXIME
Product NDC 68180-416
11-digit product format 681800416
Labeler code 68180
Product ID 68180-416_9f4604c0-f7f8-4e7a-8a19-7a60c416da66
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEFIXIME
Dosage form CAPSULE
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA065129
Marketing category ANDA
Marketing start 2018-12-01
Marketing end 0000-00-00
Substance CEFIXIME
Active strength 400 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2019-12-31
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 · 39 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68180-416-11 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68180-416-08 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68180-416-11 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68180-416-08 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68180-416-08 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68180-416-11 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68180-416-08 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68180-416-11 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68180-416-08 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68180-416-11 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68180-416-08 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68180-416-11 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68180-416-08 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68180-416-11 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68180-416-11 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68180-416-08 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68180-416-11 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68180-416-08 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68180-416-11 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68180-416-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68180-416-11 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68180-416-08 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68180-416-11 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68180-416-08 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68180-416-08 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68180-416-11 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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 Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 68180-416-08 2020-10-27 These highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986 68180-416-08 2020-10-27 These highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986 68180-416-11 2020-10-27 These highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986 68180-416-11 2020-10-27 These highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986 68180-416-08 2020-01-31 These highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986 68180-416-08 2020-01-31 These highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986 68180-416-11 2020-01-31 These highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986 68180-416-11 2020-01-31 These highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-416-08 CEFIXIME 50 in 1 BOTTLE CAPSULE 50 14 68180-416-11 CEFIXIME 10 in 1 BLISTER PACK CAPSULE 10 14 68180-416-11 CEFIXIME 1 in 1 CARTON CAPSULE 1 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFIXIME ACTIVE INGREDIENT 97I1C92E55 CEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 1 CEFIXIME ANHYDROUS ACTIVE MOIETY XZ7BG04GJX CEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 1 STRAWBERRY INACTIVE INGREDIENT 4J2TY8Y81V CEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 CEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-416 CEFIXIME POWDER, FOR SUSPENSION CEFIXIME CAPSULE [LUPIN PHARMACEUTICALS, INC.] 12 Legacy NDC, 3 package rows 20250130_6d68dbd9-7d75-4ff1-91db-79ff8ae879ec.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 68180-416-08 68180041608 50 in 1 BOTTLE Historical 68180-416-11 68180041611 10 in 1 BLISTER PACK Historical