Home NDC 0143-9670 Cefotetan
Product NDC 0143-9670
11-digit product format 001439670
Labeler code 0143
Product ID 0143-9670_239c7e32-be35-41ea-b466-2e15d3339398
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefotetan
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA091031
Marketing category ANDA
Marketing start 2011-10-26
Substance CEFOTETAN
Active strength 1 g/1
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 A091031-001 CEFOTETAN CEFOTETAN DISODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 A091031-002 CEFOTETAN CEFOTETAN DISODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26
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 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-10-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-10-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2011-10-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091031-001 CEFOTETAN EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2011-10-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091031-002 CEFOTETAN EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2011-10-26 782e0a99824c…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Cefotetan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFOTETAN 1 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 48SPP0PA9Q 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 0143-9670-01 Cefotetan 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 4 0143-9670-10 Cefotetan 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9670 CEFOTETAN INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240413_33b13b93-58ce-44c7-b9a2-af3b3a333f80.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 0143-9670-01 00143967001 1 in 1 VIAL Historical 0143-9670-10 00143967010 10 VIAL in 1 CARTON (0143-9670-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9670-01) 10 vial 2011-10-26 0000-00-00 No No Current