Home NDC 55648-986 CEFOTAXIME
Product NDC 55648-986
11-digit product format 556480986
Labeler code 55648
Product ID 55648-986_ae6f86a8-6a5c-4c3a-a8cb-aee20b427b5b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEFOTAXIME
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler WOCKHARDT LIMITED
Application ANDA065197
Marketing category ANDA
Marketing start 2006-08-29
Marketing end 0000-00-00
Substance CEFOTAXIME SODIUM
Active strength 1 g/mL
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record
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 2 · 88 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065197-001 CEFOTAXIME CEFOTAXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-08-29 A065197-002 CEFOTAXIME SODIUM CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2008-06-20 A065197-003 CEFOTAXIME SODIUM CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2008-06-20
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 4 · 129 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 2026-09-14 22:38:34 2026-08 A065197-001 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-08-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065197-002 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2008-06-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065197-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2008-06-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065197-001 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065197-002 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2008-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065197-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2008-06-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065197-001 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065197-002 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2008-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065197-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2008-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065197-001 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065197-002 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2008-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065197-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2008-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065197-001 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065197-002 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2008-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065197-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2008-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065197-001 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065197-002 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2008-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065197-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2008-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065197-001 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065197-002 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2008-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065197-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2008-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065197-001 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-08-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065197-002 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2008-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065197-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2008-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065197-001 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-08-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065197-002 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2008-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065197-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2008-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065197-001 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-08-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065197-002 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2008-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065197-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2008-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065197-001 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-08-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065197-002 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2008-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065197-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2008-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065197-001 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-08-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065197-002 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2008-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065197-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2008-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065197-001 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-08-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065197-002 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2008-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065197-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2008-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065197-001 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-08-29 301d65b070ca…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55648-986-01 CEFOTAXIME 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 1 55648-986-01 CEFOTAXIME 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, FOR SOLUTION 10 1 55648-986-02 CEFOTAXIME 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 1 55648-986-03 CEFOTAXIME 25 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 25 1 55648-986-04 CEFOTAXIME 50 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 50 1
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55648-986 CEFOTAXIME INJECTION, POWDER, FOR SOLUTION [WOCKHARDT LIMITED] 1 Legacy NDC, 5 package rows 20101026_a401a44e-2c5c-4c4a-81d8-56a3ef9d57f7.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 55648-986-01 55648098601 1 in 1 CARTON Historical 55648-986-02 55648098602 10 in 1 CARTON Historical 55648-986-03 55648098603 25 in 1 CARTON Historical 55648-986-04 55648098604 50 in 1 CARTON Historical