Home NDC 62756-073 INFUGEM
Product NDC 62756-073
11-digit product format 627560073
Labeler code 62756
Product ID 62756-073_88ff4968-c7f9-4cf5-8cd0-4793df7e8313
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gemcitabine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sun Pharmaceutical Industries, Inc.
Application NDA208313
Marketing category NDA
Marketing start 2018-10-01
Marketing end 0000-00-00
Substance GEMCITABINE HYDROCHLORIDE
Active strength 10 mg/mL
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
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 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 62756-073-60 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 62756-073-60 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 62756-073-60 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 62756-073-60 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 62756-073-60 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 62756-073-60 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 62756-073-60 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 62756-073-60 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 62756-073-60 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 62756-073-60 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 62756-073-60 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 62756-073-60 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 10 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208313-001 INFUGEM GEMCITABINE HYDROCHLORIDE EQ 1200MG BASE/120ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 N208313-002 INFUGEM GEMCITABINE HYDROCHLORIDE EQ 1300MG BASE/130ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 N208313-003 INFUGEM GEMCITABINE HYDROCHLORIDE EQ 1400MG BASE/140ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 N208313-004 INFUGEM GEMCITABINE HYDROCHLORIDE EQ 1500MG BASE/150ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 N208313-005 INFUGEM GEMCITABINE HYDROCHLORIDE EQ 1600MG BASE/160ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 N208313-006 INFUGEM GEMCITABINE HYDROCHLORIDE EQ 1700MG BASE/170ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 N208313-007 INFUGEM GEMCITABINE HYDROCHLORIDE EQ 1800MG BASE/180ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 N208313-008 INFUGEM GEMCITABINE HYDROCHLORIDE EQ 1900MG BASE/190ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 N208313-009 INFUGEM GEMCITABINE HYDROCHLORIDE EQ 2000MG BASE/200ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 N208313-010 INFUGEM GEMCITABINE HYDROCHLORIDE EQ 2200MG BASE/220ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208313-001 9241948 2033-07-01 Drug product 2018-07-25 N208313-002 9241948 2033-07-01 Drug product 2018-07-25 N208313-003 9241948 2033-07-01 Drug product 2018-07-25 N208313-004 9241948 2033-07-01 Drug product 2018-07-25 N208313-005 9241948 2033-07-01 Drug product 2018-07-25 N208313-006 9241948 2033-07-01 Drug product 2018-07-25 N208313-007 9241948 2033-07-01 Drug product 2018-07-25 N208313-008 9241948 2033-07-01 Drug product 2018-07-25 N208313-009 9241948 2033-07-01 Drug product 2018-07-25 N208313-010 9241948 2033-07-01 Drug product 2018-07-25
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 11 · 420 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 N208313-001 INFUGEM EQ 1200MG BASE/120ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-002 INFUGEM EQ 1300MG BASE/130ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-003 INFUGEM EQ 1400MG BASE/140ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-004 INFUGEM EQ 1500MG BASE/150ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-005 INFUGEM EQ 1600MG BASE/160ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-006 INFUGEM EQ 1700MG BASE/170ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-007 INFUGEM EQ 1800MG BASE/180ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-008 INFUGEM EQ 1900MG BASE/190ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-009 INFUGEM EQ 2000MG BASE/200ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-010 INFUGEM EQ 2200MG BASE/220ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208313-001 INFUGEM EQ 1200MG BASE/120ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-002 INFUGEM EQ 1300MG BASE/130ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-003 INFUGEM EQ 1400MG BASE/140ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-004 INFUGEM EQ 1500MG BASE/150ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-005 INFUGEM EQ 1600MG BASE/160ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-006 INFUGEM EQ 1700MG BASE/170ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-007 INFUGEM EQ 1800MG BASE/180ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-008 INFUGEM EQ 1900MG BASE/190ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-009 INFUGEM EQ 2000MG BASE/200ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-010 INFUGEM EQ 2200MG BASE/220ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-001 INFUGEM EQ 1200MG BASE/120ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-002 INFUGEM EQ 1300MG BASE/130ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-003 INFUGEM EQ 1400MG BASE/140ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-004 INFUGEM EQ 1500MG BASE/150ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-005 INFUGEM EQ 1600MG BASE/160ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-006 INFUGEM EQ 1700MG BASE/170ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-007 INFUGEM EQ 1800MG BASE/180ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-008 INFUGEM EQ 1900MG BASE/190ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-009 INFUGEM EQ 2000MG BASE/200ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-010 INFUGEM EQ 2200MG BASE/220ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208313-001 INFUGEM EQ 1200MG BASE/120ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-002 INFUGEM EQ 1300MG BASE/130ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-003 INFUGEM EQ 1400MG BASE/140ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-004 INFUGEM EQ 1500MG BASE/150ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-005 INFUGEM EQ 1600MG BASE/160ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-006 INFUGEM EQ 1700MG BASE/170ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-007 INFUGEM EQ 1800MG BASE/180ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-008 INFUGEM EQ 1900MG BASE/190ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-009 INFUGEM EQ 2000MG BASE/200ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-010 INFUGEM EQ 2200MG BASE/220ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2018-07-16 6a471c1ec25d…
Observed Orange Book patent history# Patent history page 1 of 11 · 420 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N208313-001 9241948 2033-07-01 Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-002 9241948 2033-07-01 Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-003 9241948 2033-07-01 Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-004 9241948 2033-07-01 Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-005 9241948 2033-07-01 Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-006 9241948 2033-07-01 Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-007 9241948 2033-07-01 Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-008 9241948 2033-07-01 Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-009 9241948 2033-07-01 Drug product 2018-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208313-010 9241948 2033-07-01 Drug product 2018-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208313-001 9241948 2033-07-01 Drug product 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-002 9241948 2033-07-01 Drug product 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-003 9241948 2033-07-01 Drug product 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-004 9241948 2033-07-01 Drug product 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-005 9241948 2033-07-01 Drug product 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-006 9241948 2033-07-01 Drug product 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-007 9241948 2033-07-01 Drug product 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-008 9241948 2033-07-01 Drug product 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-009 9241948 2033-07-01 Drug product 2018-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208313-010 9241948 2033-07-01 Drug product 2018-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-001 9241948 2033-07-01 Drug product 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-002 9241948 2033-07-01 Drug product 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-003 9241948 2033-07-01 Drug product 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-004 9241948 2033-07-01 Drug product 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-005 9241948 2033-07-01 Drug product 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-006 9241948 2033-07-01 Drug product 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-007 9241948 2033-07-01 Drug product 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-008 9241948 2033-07-01 Drug product 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-009 9241948 2033-07-01 Drug product 2018-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208313-010 9241948 2033-07-01 Drug product 2018-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208313-001 9241948 2033-07-01 Drug product 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-002 9241948 2033-07-01 Drug product 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-003 9241948 2033-07-01 Drug product 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-004 9241948 2033-07-01 Drug product 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-005 9241948 2033-07-01 Drug product 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-006 9241948 2033-07-01 Drug product 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-007 9241948 2033-07-01 Drug product 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-008 9241948 2033-07-01 Drug product 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-009 9241948 2033-07-01 Drug product 2018-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208313-010 9241948 2033-07-01 Drug product 2018-07-25 6a471c1ec25d…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62756-073-60 62756007360 1 POUCH in 1 CARTON (62756-073-60) > 1 BAG in 1 POUCH > 120 mL in 1 BAG 1 pouch 2018-10-01 0000-00-00 No No Current