Home NDC 67877-584 CEFIXIME
Product NDC 67877-584
11-digit product format 678770584
Labeler code 67877
Product ID 67877-584_a6a8aa6e-4bdf-428d-9ced-82a541cac441
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEFIXIME
Dosage form CAPSULE
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA210574
Marketing category ANDA
Marketing start 2018-10-12
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 c2088c7a36db…2026-09-14 22:38:34 2026-08 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 84e616aacf4f…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…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-584 CEFIXIME CAPSULE [ASCEND LABORATORIES, LLC] 10 Current NDC, Legacy NDC, 5 package rows 20220603_6f1df975-f825-4301-87da-d7eba56a6890.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 67877-584-01 67877058401 100 CAPSULE in 1 BOTTLE (67877-584-01) 100 capsule 2018-10-12 0000-00-00 No No Current 67877-584-05 67877058405 500 CAPSULE in 1 BOTTLE (67877-584-05) 500 capsule 2018-10-12 0000-00-00 No No Current 67877-584-33 67877058433 10 BLISTER PACK in 1 CARTON (67877-584-33) / 10 CAPSULE in 1 BLISTER PACK 10 blister pack 2020-11-26 0000-00-00 No No Current 67877-584-50 67877058450 50 CAPSULE in 1 BOTTLE (67877-584-50) 50 capsule 2018-10-12 0000-00-00 No No Current