gemcitabine

Product NDC: 25021-235
11-digit product format: 250210235
Labeler code: 25021
Product ID: 25021-235_95123b19-2847-4cb8-8736-ecca1399bb81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gemcitabine hydrochloride
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA202485
Marketing category: ANDA
Marketing start: 2014-12-29
Substance: GEMCITABINE HYDROCHLORIDE
Active strength: 1 g/25mL
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A202485-001	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07
A202485-002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202485-001	AP
A202485-002	AP

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 · 86 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
2026-09-14 22:38:34	2026-08	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2013-05-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202485-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2013-05-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202485-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2013-05-07	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202485-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202485-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202485-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202485-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202485-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202485-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202485-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202485-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202485-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202485-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202485-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202485-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202485-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202485-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202485-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202485-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202485-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202485-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202485-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202485-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202485-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202485-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202485-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202485-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202485-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202485-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202485-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202485-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202485-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202485-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202485-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202485-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202485-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202485-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202485-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202485-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202485-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202485-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202485-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202485-002	AP	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: gemcitabine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GEMCITABINE HYDROCHLORIDE	1 g/25mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
a2b7d477-0e35-4772-8a9d-99c71e3e210b	Product name	2	20190614
4c31c9b8-06d5-4f83-9eb7-cd946af7067a	Product name	5	20190612
a12a1c0c-65f2-45a0-8bf0-7dfc55c750b6	Product name	1	20180829
d2980057-8cff-4896-979e-b4c394974cfd	Product name	1	20170829
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
25021-235-50	gemcitabine	25 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	25	12
25021-235-50	gemcitabine	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1	12
25021-235-51	gemcitabine	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10	12
25021-235-51	gemcitabine	25 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	25	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-235-50	EA - Each	25021-235	15d05d79-a660-452e-97ae-1f2312d26c2f	1	2015-01-05
25021-235-51	EA - Each	25021-235	686e1c2d-714e-4af7-bcfd-d5207d6915b6	1	2023-04-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
gemcitabine hydrochloride	ACTIVE INGREDIENT	U347PV74IL	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]	2
gemcitabine	ACTIVE MOIETY	B76N6SBZ8R	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]	2
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]	2
mannitol	INACTIVE INGREDIENT	3OWL53L36A	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]	2
sodium acetate	INACTIVE INGREDIENT	4550K0SC9B	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]	2
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25021-235	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]	12	Current NDC, Legacy NDC, 4 package rows	20240918_44bcc16c-341d-49e8-a1c6-95d084667aca.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1719003	gemcitabine 1 GM Injection	PSN	44bcc16c-341d-49e8-a1c6-95d084667aca	12
1719000	gemcitabine 200 MG Injection	PSN	44bcc16c-341d-49e8-a1c6-95d084667aca	12
1719003	gemcitabine 1000 MG Injection	SCD	44bcc16c-341d-49e8-a1c6-95d084667aca	12
1719000	gemcitabine 200 MG Injection	SCD	44bcc16c-341d-49e8-a1c6-95d084667aca	12
1719003	gemcitabine (as gemcitamine HCl) 1 GM Injection	SY	44bcc16c-341d-49e8-a1c6-95d084667aca	12
1719000	gemcitabine (as gemcitamine HCl) 200 MG Injection	SY	44bcc16c-341d-49e8-a1c6-95d084667aca	12
1719003	gemcitabine 1 GM Injection	SY	44bcc16c-341d-49e8-a1c6-95d084667aca	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25021-235-50	25021023550	1 VIAL in 1 CARTON (25021-235-50) / 25 mL in 1 VIAL	1 vial	2014-12-29	0000-00-00	No	No	Current
25021-235-51	25021023551	10 VIAL in 1 CARTON (25021-235-51) / 25 mL in 1 VIAL	10 vial	2022-12-15	0000-00-00	No	No	Current