Gemcitabine

Product NDC: 72485-221
11-digit product format: 724850221
Labeler code: 72485
Product ID: 72485-221_52a15e83-e33d-42e7-9270-636b5b59d63b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GEMCITABINE HYDROCHLORIDE
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Armas Pharmaceuticals Inc.
Application: ANDA210991
Marketing category: ANDA
Marketing start: 2020-01-15
Marketing end: 0000-00-00
Substance: GEMCITABINE HYDROCHLORIDE
Active strength: 200 mg/5.26mL
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

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	72485-221		D	Discontinued by firm		2026-10-15
excluded package	package	72485-221	72485-221-02	D	Discontinued by firm		2026-10-15

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	TE codes	Approval date
A210991-001	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04
A210991-002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04
A210991-003	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A210991-001	AP
A210991-002	AP
A210991-003	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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A210991-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210991-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210991-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210991-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210991-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210991-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210991-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210991-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210991-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210991-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210991-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210991-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210991-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210991-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210991-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210991-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210991-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210991-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210991-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210991-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210991-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210991-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210991-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210991-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210991-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210991-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210991-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210991-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210991-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210991-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210991-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210991-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210991-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210991-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210991-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210991-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210991-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210991-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210991-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210991-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210991-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210991-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210991-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210991-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210991-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210991-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210991-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210991-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210991-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210991-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210991-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210991-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210991-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210991-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210991-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210991-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210991-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210991-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210991-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210991-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210991-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210991-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210991-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210991-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210991-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210991-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210991-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210991-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210991-003	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210991-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210991-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210991-003	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210991-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210991-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210991-003	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210991-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210991-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210991-003	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210991-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210991-002	AP	1	`c0c555d07b60…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72485-221-02	Gemcitabine	1 in 1 CARTON	INJECTION	1		1
72485-221-02	Gemcitabine	5.26 mL in 1 VIAL, SINGLE-DOSE	INJECTION	5.26		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72485-221-02	ML - Milliliter	72485-221	b2f20b59-52d5-40dc-962c-2bb4900faaa0	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72485-221	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION [ARMAS PHARMACEUTICALS INC.]	1	Legacy NDC, 2 package rows	20200117_57b80f66-208d-4903-9443-e4c9239e3207.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
1720977	gemcitabine 200 MG in 5.26 ML Injection	PSN	57b80f66-208d-4903-9443-e4c9239e3207	1
1720977	5.26 ML gemcitabine 38 MG/ML Injection	SCD	57b80f66-208d-4903-9443-e4c9239e3207	1
1720977	gemcitabine (as gemcitamine HCl) 200 MG per 5.26 ML Injection	SY	57b80f66-208d-4903-9443-e4c9239e3207	1
1720977	gemcitabine 200 MG per 5.26 ML Injection	SY	57b80f66-208d-4903-9443-e4c9239e3207	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72485-221-02	72485022102	1 VIAL, SINGLE-DOSE in 1 CARTON (72485-221-02) > 5.26 mL in 1 VIAL, SINGLE-DOSE	2020-01-15	0000-00-00	No	No	Current