Home NDC 62250-664-27 Cefixime
Product NDC 62250-664
Requested package NDC 62250-664-27
11-digit product format 622500664
Labeler code 62250
Product ID 62250-664_efe45e1a-35b7-0a0d-e053-2a95a90aff45
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cefixime
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Belcher Pharmaceuticals,LLC
Application ANDA206938
Marketing category ANDA
Marketing start 2017-03-15
Marketing end 0000-00-00
Substance CEFIXIME
Active strength 200 mg/5mL
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 5 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 A206938-001 CEFIXIME CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 A206938-002 CEFIXIME CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06
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 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206938-001 CEFIXIME 100MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206938-002 CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB 2017-02-06 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 62250-664-26 2025-02-11 These highlights do not include all the information needed to use CEFIXIME FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CEFIXIME FOR ORAL SUSPENSION. CEFIXIME for Oral Suspension USP, 100 mg/5 mL CEFIXIME for Oral Suspension USP, 200 mg/5 mL For oral administration Initial U.S. Approval:1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefixime for oral suspension, USP and other antibacterial drugs, Cefixime for oral suspension, U 62250-664-27 2025-02-11 These highlights do not include all the information needed to use CEFIXIME FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CEFIXIME FOR ORAL SUSPENSION. CEFIXIME for Oral Suspension USP, 100 mg/5 mL CEFIXIME for Oral Suspension USP, 200 mg/5 mL For oral administration Initial U.S. Approval:1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefixime for oral suspension, USP and other antibacterial drugs, Cefixime for oral suspension, U 62250-664-28 2025-02-11 These highlights do not include all the information needed to use CEFIXIME FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CEFIXIME FOR ORAL SUSPENSION. CEFIXIME for Oral Suspension USP, 100 mg/5 mL CEFIXIME for Oral Suspension USP, 200 mg/5 mL For oral administration Initial U.S. Approval:1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefixime for oral suspension, USP and other antibacterial drugs, Cefixime for oral suspension, U 62250-664-26 2025-01-30 These highlights do not include all the information needed to use CEFIXIME FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CEFIXIME FOR ORAL SUSPENSION. CEFIXIME for Oral Suspension USP, 100 mg/5 mL CEFIXIME for Oral Suspension USP, 200 mg/5 mL For oral administration Initial U.S. Approval:1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefixime for oral suspension, USP and other antibacterial drugs, Cefixime for oral suspension, U 62250-664-27 2025-01-30 These highlights do not include all the information needed to use CEFIXIME FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CEFIXIME FOR ORAL SUSPENSION. CEFIXIME for Oral Suspension USP, 100 mg/5 mL CEFIXIME for Oral Suspension USP, 200 mg/5 mL For oral administration Initial U.S. Approval:1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefixime for oral suspension, USP and other antibacterial drugs, Cefixime for oral suspension, U 62250-664-28 2025-01-30 These highlights do not include all the information needed to use CEFIXIME FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CEFIXIME FOR ORAL SUSPENSION. CEFIXIME for Oral Suspension USP, 100 mg/5 mL CEFIXIME for Oral Suspension USP, 200 mg/5 mL For oral administration Initial U.S. Approval:1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefixime for oral suspension, USP and other antibacterial drugs, Cefixime for oral suspension, U
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62250-664 CEFIXIME POWDER, FOR SUSPENSION [BELCHER PHARMACEUTICALS,LLC] 11 Legacy NDC 20250213_54db9828-803c-4e82-8202-cee919330786.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62250-664-27 62250066427 75 mL in 1 BOTTLE (62250-664-27) 75 ml 2017-03-15 0000-00-00 No No Current