Home NDC 27437-206-03 SUPRAX
Product NDC 27437-206
Requested package NDC 27437-206-03
11-digit product format 274370206
Labeler code 27437
Product ID 27437-206_0e44b51b-cba9-4dc5-8ee1-2d151ad24def
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cefixime
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA065355
Marketing category ANDA
Marketing start 2007-06-01
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 2020-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065355-001 SUPRAX CEFIXIME 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065355-001 AB
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 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 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065355-001 SUPRAX 200MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-10 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFIXIME ACTIVE INGREDIENT 97I1C92E55 SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 CEFIXIME ANHYDROUS ACTIVE MOIETY XZ7BG04GJX SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 GELATIN INACTIVE INGREDIENT 2G86QN327L SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 MANNITOL INACTIVE INGREDIENT 3OWL53L36A SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 SHELLAC INACTIVE INGREDIENT 46N107B71O SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 STRAWBERRY INACTIVE INGREDIENT 4J2TY8Y81V SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 SUCROSE INACTIVE INGREDIENT C151H8M554 SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE SUPRAX (CEFIXIME) TABLET SUPRAX (CEFIXIME) CAPSULE SUPRAX (CEFIXIME) TABLET, CHEWABLE SUPRAX (CEFIXIME) POWDER, FOR SUSPENSION [LUPIN PHARMA] 5
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CEFIXIME CEFIXIME Lupin Pharmaceuticals, Inc. 6d68dbd9-7d75-4ff1-91db-79ff8ae879ec 2025-10-14 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065355 application number: ANDA065355
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 27437-206-03 27437020603 50 mL in 1 BOTTLE (27437-206-03) 50 ml 2007-06-01 0000-00-00 No No Current