SUPRAX

Product NDC
68180-202
11-digit product format
681800202
Labeler code
68180
Product ID
68180-202_c1319364-40a7-4e77-a647-bf14c7256bc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFIXIME
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA065129
Marketing category
ANDA
Marketing start
2004-03-01
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
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68180-202DDiscontinued by firm2026-08-17
excluded packagepackage68180-20268180-202-01DDiscontinued by firm2026-08-17
excluded packagepackage68180-20268180-202-02DDiscontinued by firm2026-08-17
excluded packagepackage68180-20268180-202-03DDiscontinued by firm2026-08-17
excluded packagepackage68180-20268180-202-05DDiscontinued 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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68180-202-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68180-202-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68180-202-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68180-202-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68180-202-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68180-202-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68180-202-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68180-202-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68180-202-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68180-202-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68180-202-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68180-202-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68180-202-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68180-202-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68180-202-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68180-202-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68180-202-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68180-202-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68180-202-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68180-202-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68180-202-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68180-202-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68180-202-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68180-202-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68180-202-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68180-202-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68180-202-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68180-202-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68180-202-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68180-202-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68180-202-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68180-202-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68180-202-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68180-202-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68180-202-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68180-202-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68180-202-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68180-202-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68180-202-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68180-202-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68180-202-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68180-202-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68180-202-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68180-202-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68180-202-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68180-202-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68180-202-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68180-202-01557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065129-001SUPRAXCEFIXIME100MG/5MLFOR SUSPENSION / ORAL2004-02-23

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORALAB2004-02-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORALAB2004-02-233f01610625f2…
2019-09-15 20:21 UTC2019-09A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORALAB2004-02-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORALAB2004-02-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065129-001SUPRAX100MG/5MLFOR SUSPENSION / ORAL2004-02-23e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A065129-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A065129-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065129-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065129-001AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-202-01ML - Milliliter68180-202f298fa1b-9b7d-405e-9d49-3e3b1c6a417a12012-07-24
68180-202-02ML - Milliliter68180-20276d189e8-dc5c-47da-8028-7091237a5f8512015-10-02
68180-202-03ML - Milliliter68180-202e0e973e9-5e49-4587-9135-0ba8023f034012012-07-24

DailyMed Socrata Ingredients#

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CEFIXIMECEFIXIMELupin Pharmaceuticals, Inc.6d68dbd9-7d75-4ff1-91db-79ff8ae879ec2025-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065129
application number: ANDA065129

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-202-0168180020201100 mL in 1 BOTTLE (68180-202-01) 100 ml2004-03-010000-00-00NoNoCurrent
68180-202-026818002020275 mL in 1 BOTTLE (68180-202-02) 75 ml2004-03-010000-00-00NoNoCurrent
68180-202-036818002020350 mL in 1 BOTTLE (68180-202-03) 50 ml2004-03-010000-00-00NoNoCurrent
68180-202-05681800202056 BOTTLE in 1 CARTON (68180-202-05) > 10 mL in 1 BOTTLE (68180-202-04) 6 bottle2004-03-010000-00-00NoNoCurrent