Home NDC 63323-386 Cefotetan
Product NDC 63323-386
11-digit product format 633230386
Labeler code 63323
Product ID 63323-386_a30c7fcf-f9c0-4b38-bfed-fbd3b1a3e2f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEFOTETAN DISODIUM
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA065374
Marketing category ANDA
Marketing start 2009-11-18
Substance CEFOTETAN DISODIUM
Active strength 2 g/20mL
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 A065374-001 CEFOTETAN CEFOTETAN DISODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 A065374-002 CEFOTETAN CEFOTETAN DISODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09
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 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065374-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065374-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2007-08-09 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cefotetan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFOTETAN DISODIUM 2 g/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0GXP746VXB Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1722919 Internal RxNorm lookup 1722921 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 63323-386-01 Cefotetan 20 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 20 9 63323-386-20 Cefotetan 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-386 CEFOTETAN (CEFOTETAN DISODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] 9 Current NDC, Legacy NDC, 2 package rows 20250116_bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e.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.
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 63323-386-01 63323038601 20 mL in 1 VIAL 20 ml Historical 63323-386-20 63323038620 10 VIAL in 1 CARTON (63323-386-20) / 20 mL in 1 VIAL (63323-386-01) 10 vial 2009-11-18 0000-00-00 No No Current