Home NDC 64980-430 Cefixime
Product NDC 64980-430
11-digit product format 649800430
Labeler code 64980
Product ID 64980-430_245dc39b-0d41-410f-bbb9-fe1d24eeb8b2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefixime
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA206358
Marketing category ANDA
Marketing start 2025-12-12
Substance CEFIXIME
Active strength 400 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A206358-001 CEFIXIME CEFIXIME 400MG TABLET / ORAL RS 2024-12-17
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.
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 A206358-001 CEFIXIME 400MG TABLET / ORAL RS 2024-12-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206358-001 CEFIXIME 400MG TABLET / ORAL RS 2024-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206358-001 CEFIXIME 400MG TABLET / ORAL 2024-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206358-001 CEFIXIME 400MG TABLET / ORAL 2024-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206358-001 CEFIXIME 400MG TABLET / ORAL RS 2024-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206358-001 CEFIXIME 400MG TABLET / ORAL RS 2024-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206358-001 CEFIXIME 400MG TABLET / ORAL RS 2024-12-17 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206358-001 CEFIXIME 400MG TABLET / ORAL RS 2024-12-17 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Cefixime
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFIXIME 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 97I1C92E55 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197451 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64980-430-01 Cefixime 10 in 1 BOTTLE, PLASTIC TABLET 10 3
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64980-430-01 64980043001 10 TABLET in 1 BOTTLE, PLASTIC (64980-430-01) 10 tablet 2025-12-12 No No Current