Home NDC 65862-752 Cefixime
Product NDC 65862-752
11-digit product format 658620752
Labeler code 65862
Product ID 65862-752_141b12c3-31de-4ca7-ac89-d864975846ab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cefixime
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA204835
Marketing category ANDA
Marketing start 2015-04-14
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204835-001 CEFIXIME CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 A204835-002 CEFIXIME CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 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 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204835-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204835-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2015-04-14 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309058 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 65862-752-50 Cefixime 50 mL in 1 BOTTLE POWDER, FOR SUSPENSION 50 9 65862-752-75 Cefixime 75 mL in 1 BOTTLE POWDER, FOR SUSPENSION 75 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-752 CEFIXIME POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 9 Current NDC, Legacy NDC, 2 package rows 20240216_068e6edd-a5fe-40d8-8dcf-ac82b78dced4.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 65862-752-50 65862075250 50 mL in 1 BOTTLE (65862-752-50) 50 ml 2015-04-14 0000-00-00 No No Current 65862-752-75 65862075275 75 mL in 1 BOTTLE (65862-752-75) 75 ml 2015-04-14 0000-00-00 No No Current