Home NDC 70518-2749-3 CEFIXIME
Product NDC 70518-2749
Requested package NDC 70518-2749-3
11-digit product format 705182749
Labeler code 70518
Product ID 70518-2749_4a8d83f6-006d-5ac4-e063-6294a90abe49
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEFIXIME
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA210574
Marketing category ANDA
Marketing start 2020-05-21
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 · 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 A210574-001 CEFIXIME CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210574-001 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 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 70518-2749-0 2023-03-13 These highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986 70518-2749-0 2023-03-13 These highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986 70518-2749-1 2023-03-13 These highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986 70518-2749-1 2023-03-13 These highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986 70518-2749-2 2023-03-13 These highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986 70518-2749-2 2023-03-13 These highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986 70518-2749-3 2023-03-13 These highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986 70518-2749-3 2023-03-13 These highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986 70518-2749-0 2023-01-30 These highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986 70518-2749-0 2023-01-30 These highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986 70518-2749-1 2023-01-30 These highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986 70518-2749-1 2023-01-30 These highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986 70518-2749-2 2023-01-30 These highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986 70518-2749-2 2023-01-30 These highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986 70518-2749-3 2023-01-30 These highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986 70518-2749-3 2023-01-30 These highlights do not include all the information needed to use CEFIXIME CAPSULES safely and effectively. See full prescribing information for CEFIXIME CAPSULES. CEFIXIME capsules, for oral use. Initial U.S. Approval: 1986
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-2749 CEFIXIME CAPSULE [REMEDYREPACK INC.] 11 Current NDC, Legacy NDC, 6 package rows 20250125_d6718f02-8eea-4c2f-9aa2-65121d9a6e4c.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 · 3 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 70518-2749-3 70518274903 2 CAPSULE in 1 BLISTER PACK (70518-2749-3) 2 capsule 2021-03-09 0000-00-00 No No Current