Home NDC 70518-3221 CEFIXIME
Product NDC 70518-3221
11-digit product format 705183221
Labeler code 70518
Product ID 70518-3221_4ecf7772-70f8-92cf-e063-6294a90a99b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEFIXIME
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA203195
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2021-09-14
Substance CEFIXIME
Active strength 400 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
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Approval date N203195-001 SUPRAX CEFIXIME 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01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N203195-001 SUPRAX 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL AB RLD, RS 2012-06-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203195-001 SUPRAX 400MG **Federal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 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 409823 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-3221 CEFIXIME CAPSULE [REMEDYREPACK INC.] 6 Current NDC, Legacy NDC, 6 package rows 20240927_3194433c-c04e-442b-9668-fbeb0a15bac7.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 70518-3221-0 70518322100 2 POUCH in 1 BOX (70518-3221-0) > 1 CAPSULE in 1 POUCH (70518-3221-1) 2 pouch 2021-09-14 0000-00-00 No No Current 70518-3221-1 70518322101 1 in 1 POUCH Historical 70518-3221-2 70518322102 2 POUCH in 1 BOX (70518-3221-2) / 1 CAPSULE in 1 POUCH (70518-3221-3) 2 pouch 2021-11-04 0000-00-00 No No Current 70518-3221-3 70518322103 1 in 1 POUCH Historical 70518-3221-4 70518322104 2 CAPSULE in 1 BOTTLE, PLASTIC (70518-3221-4) 2 capsule 2022-03-02 0000-00-00 No No Current 70518-3221-5 70518322105 2 CAPSULE in 1 BOTTLE, PLASTIC (70518-3221-5) 2 capsule 2022-06-06 0000-00-00 No No Current