Gemcitabine

Product NDC: 45963-623
11-digit product format: 459630623
Labeler code: 45963
Product ID: 45963-623_88b5e42c-b288-437a-85cc-d9031db65ac9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gemcitabine
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Actavis Pharma, Inc.
Application: ANDA204549
Marketing category: ANDA
Marketing start: 2016-04-12
Marketing end: 2020-09-30
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	45963-623		D	Discontinued by firm		2026-08-17
excluded package	package	45963-623	45963-623-57	D	Discontinued by firm		2026-08-17

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	45963-623-57	`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	45963-623-57	`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	45963-623-57	`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	45963-623-57	`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	45963-623-57	`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	45963-623-57	`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	45963-623-57	`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	45963-623-57	`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	45963-623-57	`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	45963-623-57	`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	45963-623-57	`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	45963-623-57	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A204549-001	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11
A204549-002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11
A204549-003	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204549-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204549-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204549-003	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A204549-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204549-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204549-003	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204549-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204549-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204549-003	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204549-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204549-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204549-003	AP	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45963-623-57	ML - Milliliter	45963-623	68ff34bf-f046-4748-a627-d45dac6f5a51	1	2016-05-16

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U347PV74IL	GEMCITABINE HYDROCHLORIDE	122111-03-9	GEMCITABINE HYDROCHLORIDE
B76N6SBZ8R	GEMCITABINE	95058-81-4	Gemcitabine