Home NDC 65862-083 Cefadroxil
Product NDC 65862-083
11-digit product format 658620083
Labeler code 65862
Product ID 65862-083_74923cbc-7511-447d-b6b2-b2d0e805a0f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefadroxil
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA065349
Marketing category ANDA
Marketing start 2013-04-25
Substance CEFADROXIL
Active strength 250 mg/5mL
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065349-001 CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 A065349-002 CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065349-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065349-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2013-04-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cefadroxil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFADROXIL 250 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 280111G160 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 105171 Internal RxNorm lookup 309048 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 65862-083-01 Cefadroxil 100 mL in 1 BOTTLE POWDER, FOR SUSPENSION 100 8 65862-083-50 Cefadroxil 50 mL in 1 BOTTLE POWDER, FOR SUSPENSION 50 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFADROXIL ACTIVE INGREDIENT 280111G160 CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 2 CEFADROXIL ANHYDROUS ACTIVE MOIETY Q525PA8JJB CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 2 SULFUR DIOXIDE INACTIVE INGREDIENT 0UZA3422Q4 CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-083 CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 8 Current NDC, Legacy NDC, 2 package rows 20240213_776a8dbc-e68e-4732-acf4-0133dca0f54c.zip
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65862-083-01 65862008301 100 mL in 1 BOTTLE (65862-083-01) 100 ml 2013-04-25 0000-00-00 No No Current 65862-083-50 65862008350 50 mL in 1 BOTTLE (65862-083-50) 50 ml 2013-04-25 0000-00-00 No No Current