Home NDC 68180-407-04 CEFIXIME
Product NDC 68180-407
Requested package NDC 68180-407-04
11-digit product format 681800407
Labeler code 68180
Product ID 68180-407_735f86f4-369c-4f5a-adbe-7dacea2e27b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEFIXIME
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA065355
Marketing category ANDA
Marketing start 2015-04-24
Substance CEFIXIME
Active strength 200 mg/5mL
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68180-407 68180-407-04 I Inactivated by FDA excluded / ndc_excluded.zip 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 A065355-001 SUPRAX CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065355-001 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 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CEFIXIME
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFIXIME 200 mg/5mL
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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 68180-407-03 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 68180-407-03 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 68180-407-04 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 68180-407-04 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 68180-407-03 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 68180-407-03 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 68180-407-04 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 68180-407-04 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 68180-407-03 CEFIXIME 50 mL in 1 BOTTLE POWDER, FOR SUSPENSION 50 14 68180-407-04 CEFIXIME 75 mL in 1 BOTTLE POWDER, FOR SUSPENSION 75 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 68180-407 CEFIXIME POWDER, FOR SUSPENSION CEFIXIME CAPSULE [LUPIN PHARMACEUTICALS, INC.] 12 Current NDC, Legacy NDC, 2 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 Units Marketing start Marketing end Sample Exclude flag Status 68180-407-04 68180040704 75 mL in 1 BOTTLE (68180-407-04) 75 ml 2015-04-24 0000-00-00 No No Current