Home NDC 27437-203-02 SUPRAX
Product NDC 27437-203
Requested package NDC 27437-203-02
11-digit product format 274370203
Labeler code 27437
Product ID 27437-203_0e44b51b-cba9-4dc5-8ee1-2d151ad24def
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cefixime
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA065380
Marketing category ANDA
Marketing start 2012-12-05
Marketing end 0000-00-00
Substance CEFIXIME
Active strength 100 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065380-001 SUPRAX CEFIXIME 100MG TABLET, CHEWABLE / ORAL 2010-10-25 A065380-002 SUPRAX CEFIXIME 150MG TABLET, CHEWABLE / ORAL 2010-10-25 A065380-003 SUPRAX CEFIXIME 200MG TABLET, CHEWABLE / ORAL 2010-10-25
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 4 · 132 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 2026-10-15 13:18:30 2026-09 A065380-001 SUPRAX 100MG TABLET, CHEWABLE / ORAL 2010-10-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 A065380-002 SUPRAX 150MG TABLET, CHEWABLE / ORAL 2010-10-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 A065380-003 SUPRAX 200MG TABLET, CHEWABLE / ORAL 2010-10-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 A065380-001 SUPRAX 100MG TABLET, CHEWABLE / ORAL 2010-10-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065380-002 SUPRAX 150MG TABLET, CHEWABLE / ORAL 2010-10-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065380-003 SUPRAX 200MG TABLET, CHEWABLE / ORAL 2010-10-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065380-001 SUPRAX 100MG TABLET, CHEWABLE / ORAL 2010-10-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065380-002 SUPRAX 150MG TABLET, CHEWABLE / ORAL 2010-10-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065380-003 SUPRAX 200MG TABLET, CHEWABLE / ORAL 2010-10-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065380-001 SUPRAX 100MG TABLET, CHEWABLE / ORAL 2010-10-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065380-002 SUPRAX 150MG TABLET, CHEWABLE / ORAL 2010-10-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065380-003 SUPRAX 200MG TABLET, CHEWABLE / ORAL 2010-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065380-001 SUPRAX 100MG TABLET, CHEWABLE / ORAL 2010-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065380-002 SUPRAX 150MG TABLET, CHEWABLE / ORAL 2010-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065380-003 SUPRAX 200MG TABLET, CHEWABLE / ORAL RS 2010-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065380-001 SUPRAX 100MG TABLET, CHEWABLE / ORAL 2010-10-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065380-002 SUPRAX 150MG TABLET, CHEWABLE / ORAL 2010-10-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065380-003 SUPRAX 200MG TABLET, CHEWABLE / ORAL RS 2010-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065380-001 SUPRAX 100MG TABLET, CHEWABLE / ORAL 2010-10-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065380-002 SUPRAX 150MG TABLET, CHEWABLE / ORAL 2010-10-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065380-003 SUPRAX 200MG TABLET, CHEWABLE / ORAL RS 2010-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065380-001 SUPRAX 100MG TABLET, CHEWABLE / ORAL 2010-10-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065380-002 SUPRAX 150MG TABLET, CHEWABLE / ORAL 2010-10-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065380-003 SUPRAX 200MG TABLET, CHEWABLE / ORAL RS 2010-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065380-001 SUPRAX 100MG TABLET, CHEWABLE / ORAL 2010-10-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065380-002 SUPRAX 150MG TABLET, CHEWABLE / ORAL 2010-10-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065380-003 SUPRAX 200MG TABLET, CHEWABLE / ORAL RS 2010-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065380-001 SUPRAX 100MG TABLET, CHEWABLE / ORAL 2010-10-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065380-002 SUPRAX 150MG TABLET, CHEWABLE / ORAL 2010-10-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065380-003 SUPRAX 200MG TABLET, CHEWABLE / ORAL RS 2010-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065380-001 SUPRAX 100MG TABLET, CHEWABLE / ORAL 2010-10-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065380-002 SUPRAX 150MG TABLET, CHEWABLE / ORAL 2010-10-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065380-003 SUPRAX 200MG TABLET, CHEWABLE / ORAL RS 2010-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065380-001 SUPRAX 100MG TABLET, CHEWABLE / ORAL 2010-10-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065380-002 SUPRAX 150MG TABLET, CHEWABLE / ORAL 2010-10-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065380-003 SUPRAX 200MG TABLET, CHEWABLE / ORAL RS 2010-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065380-001 SUPRAX 100MG TABLET, CHEWABLE / ORAL 2010-10-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065380-002 SUPRAX 150MG TABLET, CHEWABLE / ORAL 2010-10-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065380-003 SUPRAX 200MG TABLET, CHEWABLE / ORAL RS 2010-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065380-001 SUPRAX 100MG TABLET, CHEWABLE / ORAL 2010-10-25 79d66fd596c7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 CEFIXIME ACTIVE INGREDIENT 97I1C92E55 SUPRAX (CEFIXIME) TABLET, CHEWABLE [LUPIN PHARMA] 1 CEFIXIME ANHYDROUS ACTIVE MOIETY XZ7BG04GJX SUPRAX (CEFIXIME) TABLET, CHEWABLE [LUPIN PHARMA] 1 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 SUPRAX (CEFIXIME) TABLET, CHEWABLE [LUPIN PHARMA] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK SUPRAX (CEFIXIME) TABLET, CHEWABLE [LUPIN PHARMA] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA SUPRAX (CEFIXIME) TABLET, CHEWABLE [LUPIN PHARMA] 1 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 SUPRAX (CEFIXIME) TABLET, CHEWABLE [LUPIN PHARMA] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SUPRAX (CEFIXIME) TABLET, CHEWABLE [LUPIN PHARMA] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A SUPRAX (CEFIXIME) TABLET, CHEWABLE [LUPIN PHARMA] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SUPRAX (CEFIXIME) TABLET, CHEWABLE [LUPIN PHARMA] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 27437-203-02 27437020302 1 BLISTER PACK in 1 CARTON (27437-203-02) > 1 TABLET, CHEWABLE in 1 BLISTER PACK 1 blister pack 2012-12-05 0000-00-00 No No Current