Cefotetan and Dextrose

Product NDC
0264-3175
11-digit product format
002643175
Labeler code
0264
Product ID
0264-3175_07cdc89e-285b-4700-a224-6d675be77471
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFOTETAN and DEXTROSE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA065430
Marketing category
NDA
Marketing start
2010-08-20
Marketing end
0000-00-00
Substance
CEFOTETAN DISODIUM
Active strength
2 g/50mL
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0264-3175DDiscontinued by firm2026-08-03
excluded packagepackage0264-31750264-3175-11DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 24 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0264-3175DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0264-31750264-3175-11DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct0264-3175DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0264-31750264-3175-11DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct0264-3175DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0264-31750264-3175-11DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproduct0264-3175DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0264-31750264-3175-11DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproduct0264-3175DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0264-31750264-3175-11DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct0264-3175DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0264-31750264-3175-11DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct0264-3175DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0264-31750264-3175-11DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct0264-3175DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0264-31750264-3175-11DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0264-3175DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0264-31750264-3175-11DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct0264-3175DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0264-31750264-3175-11DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct0264-3175DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0264-31750264-3175-11DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct0264-3175DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0264-31750264-3175-11DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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
N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINERCEFOTETAN DISODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-09
N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINERCEFOTETAN DISODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-09

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 UTC2026-02N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD2007-08-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD, RS2007-08-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD, RS2007-08-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD, RS2007-08-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD, RS2007-08-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD, RS2007-08-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD, RS2007-08-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD, RS2007-08-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD, RS2007-08-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD, RS2007-08-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD, RS2007-08-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N065430-001CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD, RS2007-08-09782e0a99824c…
2021-12-28 21:50 UTC2021-12N065430-002CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINEREQ 2GM BASE/VIALINJECTABLE / INJECTIONRLD, RS2007-08-09782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-3175-11EA - Each0264-31759d88212c-7e54-4ff8-9bf5-5bbe6eb5e18512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFOTETAN DISODIUMACTIVE INGREDIENT0GXP746VXBCEFOTETAN AND DEXTROSE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]6
CEFOTETANACTIVE MOIETY48SPP0PA9QCEFOTETAN AND DEXTROSE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]6
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GCEFOTETAN AND DEXTROSE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RCEFOTETAN AND DEXTROSE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-3175-110026431751124 CONTAINER in 1 CASE (0264-3175-11) > 50 mL in 1 CONTAINER24 container2010-08-200000-00-00NoNoCurrent