Cefixime

Product NDC
62250-663
11-digit product format
622500663
Labeler code
62250
Product ID
62250-663_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
100 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62250-663DDiscontinued by firm2026-08-17
excluded packagepackage62250-66362250-663-26DDiscontinued by firm2026-08-17
excluded packagepackage62250-66362250-663-27DDiscontinued by firm2026-08-17
excluded packagepackage62250-66362250-663-28DDiscontinued by firm2026-08-17

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 · 20 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62250-663-27DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62250-663-28DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62250-663-26DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62250-663-27DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62250-663-28DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62250-663-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62250-663-26UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62250-663-28UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62250-663-27UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62250-663-26UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62250-663-28UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62250-663-27UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62250-663-26UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62250-663-28UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62250-663-27UExcluded because listing certification expired0efc9e666f02…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206938-001CEFIXIMECEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-06
A206938-002CEFIXIMECEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A206938-001AB
A206938-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-06caaa826d4ba7…
2026-08-18 06:07:402026-07A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206938-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2017-02-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206938-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2017-02-06bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206938-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206938-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206938-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206938-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206938-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206938-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206938-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206938-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206938-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206938-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206938-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206938-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206938-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206938-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206938-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206938-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206938-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206938-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206938-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206938-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206938-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206938-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206938-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206938-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206938-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206938-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206938-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206938-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206938-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206938-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206938-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206938-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206938-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206938-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206938-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206938-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206938-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206938-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206938-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206938-002AB1bb7c543d1eb4…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
62250-663-262025-02-11These 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
62250-663-272025-02-11These 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
62250-663-282025-02-11These 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
62250-663-262025-01-30These 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
62250-663-272025-01-30These 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
62250-663-282025-01-30These 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
NDCDashboard titleSPL versionValidationDashboard ZIP
62250-663CEFIXIME POWDER, FOR SUSPENSION [BELCHER PHARMACEUTICALS,LLC]11Legacy NDC20250213_54db9828-803c-4e82-8202-cee919330786.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62250-663-266225006632650 mL in 1 BOTTLE (62250-663-26) 50 ml2017-03-150000-00-00NoNoCurrent
62250-663-276225006632775 mL in 1 BOTTLE (62250-663-27) 75 ml2017-03-150000-00-00NoNoCurrent
62250-663-2862250066328100 mL in 1 BOTTLE (62250-663-28) 100 ml2017-03-150000-00-00NoNoCurrent