Cefadroxil

Product NDC
68180-181
Requested package NDC
68180-181-01
11-digit product format
681800181
Labeler code
68180
Product ID
68180-181_3818bd15-cf3a-4b07-bef5-57169a33a170
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA065396
Marketing category
ANDA
Marketing start
2008-04-23
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68180-18168180-181-01DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065396-001CEFADROXILCEFADROXIL/CEFADROXIL HEMIHYDRATEEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-21
A065396-002CEFADROXILCEFADROXIL/CEFADROXIL HEMIHYDRATEEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A065396-001AB
A065396-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065396-001CEFADROXILEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2008-02-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065396-002CEFADROXILEQ 500MG BASE/5MLFOR SUSPENSION / ORALABRS2008-02-21bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A065396-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065396-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065396-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065396-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065396-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065396-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065396-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065396-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065396-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065396-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065396-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065396-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065396-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065396-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065396-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065396-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065396-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065396-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065396-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065396-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065396-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065396-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065396-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065396-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065396-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065396-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065396-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065396-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065396-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065396-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065396-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065396-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065396-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065396-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065396-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065396-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065396-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065396-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065396-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065396-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Cefadroxil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFADROXIL250 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
280111G160Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
105171Internal RxNorm lookup
309048Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
27009a05-4d2b-4618-be76-39f348240edaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
560bed03-0257-a1db-0638-2c46fc35054cProduct name220170824
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
34f1b9ee-0673-df8c-ddae-36eaf4c48382Product name120140508
3793572a-4958-68b2-f923-8cf695ec1cc1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-181-01Cefadroxil50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION509
68180-181-02Cefadroxil100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-181-02ML - Milliliter68180-18107ff0cd4-7acb-4eab-b787-537672cf435312012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-181CEFADROXIL POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 2 package rows20250130_27009a05-4d2b-4618-be76-39f348240eda.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefadroxilCEFADROXILLupin Pharmaceuticals, Inc.27009a05-4d2b-4618-be76-39f348240eda2025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065396
application number: ANDA065396
ndc (package): 68180-181-01
ndc (product): 68180-181
ndc11 (package): 68180018101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309048cefadroxil 250 MG in 5 mL Oral SuspensionPSN27009a05-4d2b-4618-be76-39f348240eda9
105171cefadroxil 500 MG in 5 mL Oral SuspensionPSN27009a05-4d2b-4618-be76-39f348240eda9
105171cefadroxil 100 MG/ML Oral SuspensionSCD27009a05-4d2b-4618-be76-39f348240eda9
309048cefadroxil 50 MG/ML Oral SuspensionSCD27009a05-4d2b-4618-be76-39f348240eda9
105171cefadroxil (as cefadroxil monohydrate) 100 MG/ML Oral SuspensionSY27009a05-4d2b-4618-be76-39f348240eda9
309048cefadroxil (as cefadroxil monohydrate) 50 MG/ML Oral SuspensionSY27009a05-4d2b-4618-be76-39f348240eda9
309048cefadroxil 250 MG per 5 ML Powder for Oral SuspensionSY27009a05-4d2b-4618-be76-39f348240eda9
105171cefadroxil 500 MG per 5 ML Powder for Oral SuspensionSY27009a05-4d2b-4618-be76-39f348240eda9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-181-016818001810150 mL in 1 BOTTLE (68180-181-01) 50 ml2008-04-230000-00-00NoNoCurrent