Gemcitabine Hydrochloride

Product NDC: 68001-282
11-digit product format: 680010282
Labeler code: 68001
Product ID: 68001-282_c6640762-8bde-4b8a-e053-2a95a90a4673
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gemcitabine Hydrochloride
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: BluePoint Laboratories
Application: ANDA091594
Marketing category: ANDA
Marketing start: 2011-07-25
Marketing end: 2021-08-01
Substance: GEMCITABINE HYDROCHLORIDE
Active strength: 38 mg/mL
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68001-282		D	Discontinued by firm	2026-10-15
excluded package	package	68001-282	68001-282-25	D	Discontinued by firm	2026-10-15
excluded package	package	68001-282	68001-282-26	D	Discontinued by firm	2026-10-15
excluded package	package	68001-282	68001-282-27	D	Discontinued by firm	2026-10-15

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 · 48 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	68001-282-27	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68001-282-26	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68001-282-25	`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	68001-282-27	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68001-282-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68001-282-25	`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	68001-282-27	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68001-282-26	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68001-282-25	`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	68001-282-27	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68001-282-26	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68001-282-25	`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	68001-282-27	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68001-282-26	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68001-282-25	`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	68001-282-27	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68001-282-26	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68001-282-25	`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	68001-282-27	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68001-282-26	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68001-282-25	`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	68001-282-27	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68001-282-26	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68001-282-25	`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	68001-282-27	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68001-282-26	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68001-282-25	`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	68001-282-27	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68001-282-26	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68001-282-25	`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	68001-282-27	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68001-282-26	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68001-282-25	`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	68001-282-27	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68001-282-26	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68001-282-25	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A091594-001	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	2011-07-25
A091594-002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25
A091594-003	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25

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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A091594-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091594-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091594-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091594-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091594-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091594-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091594-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091594-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091594-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091594-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091594-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091594-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091594-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091594-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091594-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091594-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091594-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091594-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091594-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091594-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091594-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091594-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091594-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091594-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091594-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091594-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091594-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091594-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091594-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091594-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091594-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091594-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091594-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091594-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091594-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091594-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091594-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091594-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091594-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091594-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	2011-07-25	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091594-002	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091594-003	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091594-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A091594-002	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A091594-003	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091594-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A091594-002	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A091594-003	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091594-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091594-002	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091594-003	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091594-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091594-002	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091594-003	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091594-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091594-002	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091594-003	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091594-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091594-002	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091594-003	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091594-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A091594-002	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A091594-003	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091594-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A091594-002	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A091594-003	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091594-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091594-002	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091594-003	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091594-001	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A091594-002	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A091594-003	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091594-001	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A091594-002	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A091594-003	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091594-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091594-002	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091594-003	AP	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-282-22	EA - Each	68001-282	aeb0c7ed-5d8a-4890-96a6-6d5d9953a6e7	1	2016-07-19
68001-282-23	EA - Each	68001-282	575b59c6-8897-475d-bfdc-f976c8da75aa	1	2016-07-19
68001-282-24	EA - Each	68001-282	19e24296-3ad9-4869-b81b-042dddf1e9b8	1	2016-07-19
68001-282-25	EA - Each	68001-282	10a4f7e1-a20d-4fe1-ad2d-512744533ed4	1	2016-07-19
68001-282-26	EA - Each	68001-282	9d5e60fc-c391-43a6-b434-26e3a0e5ecb4	1	2016-07-19
68001-282-27	EA - Each	68001-282	c193ed00-cacc-4fcf-ae22-4c7668199215	1	2016-07-19

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U347PV74IL	GEMCITABINE HYDROCHLORIDE	122111-03-9	GEMCITABINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-282-25	68001028225	1 VIAL in 1 CARTON (68001-282-25) > 5 mL in 1 VIAL (68001-282-22)	1 vial	2016-05-23	0000-00-00	No	No	Current
68001-282-26	68001028226	1 VIAL in 1 CARTON (68001-282-26) > 25 mL in 1 VIAL (68001-282-23)	1 vial	2016-05-23	0000-00-00	No	No	Current
68001-282-27	68001028227	1 VIAL in 1 CARTON (68001-282-27) > 50 mL in 1 VIAL (68001-282-24)	1 vial	2016-05-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gemcitabine Hydrochloride	BluePoint Laboratories \| Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2021-07-05	HUMAN PRESCRIPTION DRUG LABEL	2