Cefdinir

Product NDC
0781-6078
11-digit product format
007816078
Labeler code
0781
Product ID
0781-6078_990055e8-68da-4714-8a9b-02fbb244b570
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA065337
Marketing category
ANDA
Marketing start
2007-04-06
Marketing end
0000-00-00
Substance
CEFDINIR
Active strength
250 mg/5mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-6078DDiscontinued by firm2026-08-17
excluded packagepackage0781-60780781-6078-46DDiscontinued by firm2026-08-17
excluded packagepackage0781-60780781-6078-61DDiscontinued 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 · 36 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 packagepackage0781-6078-61d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-6078-46d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-6078-61f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-6078-46f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-6078-612ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-6078-462ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-6078-61a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-6078-46a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-6078-61cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-6078-46cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-6078-61cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-6078-46cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-6078-61302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-6078-46302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-6078-61ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-6078-46ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-6078-610efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-6078-460efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-6078-61ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-6078-46ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-6078-61367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-6078-46367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-6078-61557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-6078-46557ba5c1ecfa…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
A065337-001CEFDINIRCEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-06
A065337-002CEFDINIRCEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065337-001AB
A065337-002AB

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 06:07:402026-07A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-04-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALABRS2007-04-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALABRS2007-04-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALABRS2007-04-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALABRS2007-04-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065337-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-04-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065337-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALABRS2007-04-06bb7c543d1eb4…

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 06:07:402026-07A065337-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065337-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065337-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065337-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065337-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065337-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065337-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065337-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065337-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065337-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065337-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065337-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065337-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065337-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065337-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065337-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065337-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065337-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065337-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065337-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065337-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065337-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065337-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065337-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065337-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065337-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065337-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065337-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065337-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065337-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065337-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065337-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065337-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065337-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065337-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065337-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065337-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065337-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065337-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065337-002AB1bb7c543d1eb4…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-6078-46ML - Milliliter0781-6078fc2abb94-e540-4a5a-93d1-dfdc1088dd8f12012-07-24
0781-6078-61ML - Milliliter0781-6078532a9038-a9de-404d-b589-dcef9e55f2d012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFDINIRACTIVE INGREDIENTCI0FAO63WCCEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC]12
CEFDINIRACTIVE MOIETYCI0FAO63WCCEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC]12
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC]12
ANHYDROUS TRISODIUM CITRATEINACTIVE INGREDIENTRS7A450LGACEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC]12
GUAR GUMINACTIVE INGREDIENTE89I1637KECEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC]12
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC]12
STRAWBERRYINACTIVE INGREDIENT4J2TY8Y81VCEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC]12
SUCROSEINACTIVE INGREDIENTC151H8M554CEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC]12
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC]12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-6078-4600781607846100 mL in 1 BOTTLE (0781-6078-46) 100 ml2007-04-060000-00-00NoNoCurrent
0781-6078-610078160786160 mL in 1 BOTTLE (0781-6078-61) 60 ml2007-04-060000-00-00NoNoCurrent