Home NDC 68180-423 CEFIXIME
Product NDC 68180-423
11-digit product format 681800423
Labeler code 68180
Product ID 68180-423_735f86f4-369c-4f5a-adbe-7dacea2e27b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEFIXIME
Dosage form CAPSULE
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application NDA203195
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2020-10-14
Substance CEFIXIME
Active strength 400 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
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 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Approval date N203195-001 SUPRAX CEFIXIME 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N203195-001 AB
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 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2012-06-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203195-001 SUPRAX 400MG CAPSULE / ORAL RLD 2012-06-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203195-001 SUPRAX 400MG CAPSULE / ORAL RLD 2012-06-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203195-001 SUPRAX 400MG CAPSULE / ORAL AB RLD, RS 2012-06-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2012-06-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE / ORAL RLD 2012-06-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203195-001 SUPRAX 400MG CAPSULE / ORAL RLD 2012-06-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203195-001 SUPRAX 400MG CAPSULE / ORAL RLD 2012-06-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203195-001 SUPRAX 400MG CAPSULE / ORAL RLD 2012-06-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203195-001 SUPRAX 400MG CAPSULE / ORAL RLD 2012-06-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203195-001 SUPRAX 400MG CAPSULE / ORAL AB RLD, RS 2012-06-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203195-001 SUPRAX 400MG CAPSULE / ORAL AB RLD, RS 2012-06-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203195-001 SUPRAX 400MG CAPSULE / ORAL AB RLD, RS 2012-06-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base CEFIXIME
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFIXIME 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 97I1C92E55 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309058 Internal RxNorm lookup 409823 Internal RxNorm lookup 419849 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 68180-423-08 CEFIXIME 50 in 1 BOTTLE CAPSULE 50 14 68180-423-11 CEFIXIME 1 in 1 CARTON CAPSULE 1 14 68180-423-11 CEFIXIME 10 in 1 BLISTER PACK CAPSULE 10 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 68180-423 CEFIXIME POWDER, FOR SUSPENSION CEFIXIME CAPSULE [LUPIN PHARMACEUTICALS, INC.] 12 Current NDC, 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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68180-423-08 68180042308 50 CAPSULE in 1 BOTTLE (68180-423-08) 50 capsule 2020-10-14 0000-00-00 No No Current 68180-423-11 68180042311 1 BLISTER PACK in 1 CARTON (68180-423-11) / 10 CAPSULE in 1 BLISTER PACK 1 blister pack 2020-10-14 0000-00-00 No No Current