Home NDC 59630-309 Doribax
Product NDC 59630-309
11-digit product format 596300309
Labeler code 59630
Product ID 59630-309_8879a2d9-9310-b59a-e053-2a95a90ab1c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doripenem
Dosage form POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Shionogi Inc.
Application NDA022106
Marketing category NDA
Marketing start 2010-10-15
Marketing end 2020-02-28
Substance DORIPENEM
Active strength 250 mg/10mL
Pharmacologic classes Carbapenems [CS],Penem Antibacterial [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 1 · 26 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59630-309-10 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 59630-309-10 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 59630-309-10 D Discontinued by firm excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 59630-309-10 D Discontinued by firm excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 59630-309-10 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 59630-309-10 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 59630-309-10 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 59630-309-10 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59630-309-10 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 59630-309-10 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 59630-309-10 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 59630-309-10 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2019-06-01 22:24 UTC · source 2019-05-30 unfinished product product UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 5b2001dcd8f5…54b53d4dc9e4…2019-06-01 22:24 UTC · source 2019-05-30 unfinished package package 59630-309-25 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 5b2001dcd8f5…54b53d4dc9e4…
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 N022106-001 DORIBAX DORIPENEM 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2007-10-12 N022106-002 DORIBAX DORIPENEM 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2010-10-05
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 N022106-001 DORIBAX 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2007-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022106-002 DORIBAX 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2010-10-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022106-001 DORIBAX 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2007-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022106-002 DORIBAX 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2010-10-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022106-001 DORIBAX 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2007-10-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022106-002 DORIBAX 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2010-10-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022106-001 DORIBAX 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2007-10-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022106-002 DORIBAX 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2010-10-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022106-001 DORIBAX 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2007-10-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022106-002 DORIBAX 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2010-10-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022106-001 DORIBAX 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2007-10-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022106-002 DORIBAX 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2010-10-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022106-001 DORIBAX 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2007-10-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022106-002 DORIBAX 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2010-10-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022106-001 DORIBAX 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2007-10-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022106-002 DORIBAX 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2010-10-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022106-001 DORIBAX 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2007-10-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022106-002 DORIBAX 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2010-10-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022106-001 DORIBAX 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2007-10-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022106-002 DORIBAX 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2010-10-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022106-001 DORIBAX 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2007-10-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022106-002 DORIBAX 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2010-10-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022106-001 DORIBAX 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2007-10-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022106-002 DORIBAX 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2010-10-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022106-001 DORIBAX 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2007-10-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022106-002 DORIBAX 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2010-10-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022106-001 DORIBAX 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2007-10-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022106-002 DORIBAX 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2010-10-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022106-001 DORIBAX 500MG/VIAL INJECTABLE / INTRAVENOUS RLD 2007-10-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022106-002 DORIBAX 250MG/VIAL INJECTABLE / INTRAVENOUS RLD 2010-10-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022106-001 DORIBAX 500MG/VIAL INJECTABLE / INTRAVENOUS RLD 2007-10-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022106-002 DORIBAX 250MG/VIAL INJECTABLE / INTRAVENOUS RLD 2010-10-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022106-001 DORIBAX 500MG/VIAL INJECTABLE / INTRAVENOUS RLD 2007-10-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022106-002 DORIBAX 250MG/VIAL INJECTABLE / INTRAVENOUS RLD 2010-10-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022106-001 DORIBAX 500MG/VIAL INJECTABLE / INTRAVENOUS RLD 2007-10-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022106-002 DORIBAX 250MG/VIAL INJECTABLE / INTRAVENOUS RLD 2010-10-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022106-001 DORIBAX 500MG/VIAL INJECTABLE / INTRAVENOUS RLD 2007-10-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022106-002 DORIBAX 250MG/VIAL INJECTABLE / INTRAVENOUS RLD 2010-10-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022106-001 DORIBAX 500MG/VIAL INJECTABLE / INTRAVENOUS RLD 2007-10-12 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022106-002 DORIBAX 250MG/VIAL INJECTABLE / INTRAVENOUS RLD 2010-10-05 782e0a99824c…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N022106-001 8247402 2021-03-30 Drug substance, Drug product 2012-09-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022106-002 8247402 2021-03-30 Drug substance, Drug product 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N022106-001 8247402 2021-03-30 Drug substance, Drug product 2012-09-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022106-002 8247402 2021-03-30 Drug substance, Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022106-001 8247402 2021-03-30 Drug substance, Drug product 2012-09-13 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022106-002 8247402 2021-03-30 Drug substance, Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022106-001 8247402 2021-03-30 Drug substance, Drug product 2012-09-13 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022106-002 8247402 2021-03-30 Drug substance, Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022106-001 8247402 2021-03-30 Drug substance, Drug product 2012-09-13 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022106-002 8247402 2021-03-30 Drug substance, Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022106-001 8247402 2021-03-30 Drug substance, Drug product 2012-09-13 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022106-002 8247402 2021-03-30 Drug substance, Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022106-001 8247402 2021-03-30 Drug substance, Drug product 2012-09-13 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022106-002 8247402 2021-03-30 Drug substance, Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022106-001 8247402 2021-03-30 Drug substance, Drug product 2012-09-13 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022106-002 8247402 2021-03-30 Drug substance, Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022106-001 8247402 2021-03-30 Drug substance, Drug product 2012-09-13 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022106-002 8247402 2021-03-30 Drug substance, Drug product ea99ee380514…
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