CEFDINIR

Product NDC
72189-042
11-digit product format
721890042
Labeler code
72189
Product ID
72189-042_92c0f898-1f5e-c28e-e053-2995a90a9d66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFDINIR
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Direct_Rx
Application
ANDA065259
Marketing category
ANDA
Marketing start
2019-09-17
Marketing end
0000-00-00
Substance
CEFDINIR
Active strength
125 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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72189-042IInactivated by FDA2026-08-03
excluded packagepackage72189-04272189-042-32IInactivated by FDA2026-08-03

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage72189-042-32d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage72189-042-32f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage72189-042-322ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage72189-042-32a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage72189-042-32cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage72189-042-32cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage72189-042-32302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-042-32ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-042-320efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage72189-042-32ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage72189-042-32367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage72189-042-32557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage72189-042-328af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage72189-042-32834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage72189-042-321332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065259-001CEFDINIRCEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-31
A065259-002CEFDINIRCEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065259-001AB
A065259-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065259-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2006-05-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A065259-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-07782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065259-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065259-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065259-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065259-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065259-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065259-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065259-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065259-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065259-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065259-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065259-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065259-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065259-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065259-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065259-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065259-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065259-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065259-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065259-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065259-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065259-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065259-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065259-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065259-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065259-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065259-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065259-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065259-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065259-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065259-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065259-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065259-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065259-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065259-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065259-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065259-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065259-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065259-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065259-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065259-002AB1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d3e72f63-2c41-955f-f4ce-e90c6403e67cProduct name220210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1Product name220210729
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-042-322023-01-30C16284748780-1f386c64a-0d86-0266-e053-dadaa90a7c1aCEFDINIR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-042-32CEFDINIR100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-042-32ML - Milliliter72189-04249c60d39-af37-4495-ade8-3b303d9efab612019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-042CEFDINIR POWDER, FOR SUSPENSION [DIRECT_RX]1Legacy NDC, 1 package rows20190918_92c0f898-1f5d-c28e-e053-2995a90a9d66.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefdinirCEFDINIRPreferred Pharmaceuticals Inc.3714d558-cbaa-42e8-831b-ffbbc951ebf22026-04-21WarningsExact identifier
application applno (ANDA): 065259
application number: ANDA065259
CefdinirCEFDINIRA-S Medication Solutions17b4e82f-4169-4ab9-bd4a-79781a71e1602025-12-19WarningsExact identifier
application applno (ANDA): 065259
application number: ANDA065259
CefdinirCEFDINIRLupin Pharmaceuticals, Inc.7490df67-56c0-4a1c-8533-2107f3e8aea52025-09-23WarningsExact identifier
application applno (ANDA): 065259
application number: ANDA065259
CefdinirCEFDINIRAsclemed USA, Inc.e90660c8-2714-4592-aeaa-bc9ceb26057c2025-04-19WarningsExact identifier
application applno (ANDA): 065259
application number: ANDA065259
CefdinirCEFDINIRNuCare Pharmaceuticals, Inc.2fb43fbe-2c4b-1df9-e063-6394a90a99132025-03-06WarningsExact identifier
application applno (ANDA): 065259
application number: ANDA065259
CefdinirCEFDINIRNuCare Pharmaceuticals,Inc.fbd76f8c-e6b8-52f4-e053-6394a90aa7ab2025-02-04WarningsExact identifier
application applno (ANDA): 065259
application number: ANDA065259
CEFDINIRCEFDINIRDIRECT RX982d0f53-20bc-1cb4-e053-2995a90ad33c2025-01-22WarningsExact identifier
application applno (ANDA): 065259
application number: ANDA065259
CefdinirCEFDINIRNuCare Pharmaceuticals,Inc.1bbd75ea-5a50-eb00-e063-6394a90a1cec2024-06-25WarningsExact identifier
application applno (ANDA): 065259
application number: ANDA065259
CefdinirCEFDINIRA-S Medication Solutions37b5d000-db9e-4b6e-8208-6361e98fb55d2023-11-01WarningsExact identifier
application applno (ANDA): 065259
application number: ANDA065259
CefdinirCEFDINIRProficient Rx LP444cd2c4-836d-40d5-a307-d719fe83e7632022-05-02WarningsExact identifier
application applno (ANDA): 065259
application number: ANDA065259

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309054cefdinir 125 MG in 5 mL Oral SuspensionPSN92c0f898-1f5d-c28e-e053-2995a90a9d661
309054cefdinir 25 MG/ML Oral SuspensionSCD92c0f898-1f5d-c28e-e053-2995a90a9d661
309054cefdinir 125 MG per 5 ML Oral SuspensionSY92c0f898-1f5d-c28e-e053-2995a90a9d661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-042-3272189004232100 mL in 1 BOTTLE (72189-042-32) 100 ml2019-09-170000-00-00NoNoCurrent