Cefixime

Product NDC
43598-674
Requested package NDC
43598-674-50
11-digit product format
435980674
Labeler code
43598
Product ID
43598-674_f1643ee6-0df8-54d4-e053-2a95a90a444f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefixime
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Dr. Reddy
Application
ANDA206938
Marketing category
ANDA
Marketing start
2017-08-03
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
2024-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43598-67443598-674-50DDiscontinued 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43598-67443598-674-50DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43598-67443598-674-50DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-674-50ML - Milliliter43598-674da0ff258-6a35-4289-a2f4-c0d333e133a412017-09-11
43598-674-51ML - Milliliter43598-674ed0d10ce-aae3-4b43-98ab-175ca6ade59d12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-674CEFIXIME POWDER, FOR SUSPENSION [DR. REDDY’S LABORATORIES, INC]10Legacy NDC20231006_f5397168-0550-4ab6-8a6d-76ada66c245b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-674-504359806745050 mL in 1 BOTTLE (43598-674-50) 50 ml2017-08-030000-00-00NoNoCurrent