Home NDC 66288-8100 CEFEPIME
Product NDC 66288-8100
11-digit product format 662888100
Labeler code 66288
Product ID 66288-8100_c3258e86-4c07-4656-9767-ca959ecee86d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEFEPIME
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler SAMSON MEDICAL TECHNOLOGIES LLC
Application ANDA209408
Marketing category ANDA
Marketing start 2018-10-01
Substance CEFEPIME HYDROCHLORIDE
Active strength 100 g/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 66288-8100 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 66288-8100 66288-8100-1 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER CEFEPIME HYDROCHLORIDE EQ 100GM BASE POWDER / INTRAVENOUS RS 2018-08-21
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS RS 2018-08-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS RS 2018-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS RS 2018-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS RS 2018-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS RS 2018-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS RS 2018-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS RS 2018-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS RS 2018-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS RS 2018-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS RS 2018-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS RS 2018-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS RS 2018-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS RS 2018-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS RS 2018-08-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS RS 2018-08-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209408-001 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER EQ 100GM BASE POWDER / INTRAVENOUS 2018-08-21 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base CEFEPIME
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFEPIME HYDROCHLORIDE 100 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination I8X1O0607P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2058953 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 66288-8100-1 CEFEPIME 1 in 1 BAG INJECTION, POWDER, FOR SOLUTION 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66288-8100 CEFEPIME INJECTION, POWDER, FOR SOLUTION [SAMSON MEDICAL TECHNOLOGIES LLC] 7 Current NDC, Legacy NDC, 1 package rows 20240314_f776421b-bd46-4664-b9ff-533d805e1277.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 66288-8100-1 66288810001 1 BAG in 1 BAG (66288-8100-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG 1 bag 2018-10-01 0000-00-00 No No Current