Gemcitabine

Product NDC: 72485-222
11-digit product format: 724850222
Labeler code: 72485
Product ID: 72485-222_3f1b1931-04c8-45ba-afbb-4daf5e05a69f
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
Substance: GEMCITABINE HYDROCHLORIDE
Active strength: 1 g/26.3mL
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	72485-222		D	Discontinued by firm		2026-08-17
excluded package	package	72485-222	72485-222-10	D	Discontinued by firm		2026-08-17

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	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 3 · 120 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
2026-08-18 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210991-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210991-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210991-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210991-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210991-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210991-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2019-10-04	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210991-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210991-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210991-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210991-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210991-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210991-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210991-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210991-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210991-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210991-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210991-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210991-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210991-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210991-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210991-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210991-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210991-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210991-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210991-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210991-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210991-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210991-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210991-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210991-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210991-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210991-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210991-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210991-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210991-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210991-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210991-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210991-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210991-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210991-001	AP	1	`79d66fd596c7…`
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…`

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
72485-222-10	Gemcitabine	26.3 mL in 1 VIAL, SINGLE-DOSE	INJECTION	26.3		1
72485-222-10	Gemcitabine	1 in 1 CARTON	INJECTION	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72485-222-10	ML - Milliliter	72485-222	542541c4-62e0-4e1c-8a3f-c0309edf962f	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72485-222	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION [ARMAS PHARMACEUTICALS INC.]	1	Current NDC, Legacy NDC, 2 package rows	20200117_5b6be4b4-1f0a-4da2-b5d2-2592f401f90b.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
1720960	gemcitabine 1 GM in 26.3 ML Injection	PSN	5b6be4b4-1f0a-4da2-b5d2-2592f401f90b	1
1720960	26.3 ML gemcitabine 38 MG/ML Injection	SCD	5b6be4b4-1f0a-4da2-b5d2-2592f401f90b	1
1720960	gemcitabine (as gemcitamine HCl) 1 GM per 26.3 ML Injection	SY	5b6be4b4-1f0a-4da2-b5d2-2592f401f90b	1
1720960	gemcitabine 1 GM per 26.3 ML Injection	SY	5b6be4b4-1f0a-4da2-b5d2-2592f401f90b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72485-222-10	72485022210	1 VIAL, SINGLE-DOSE in 1 CARTON (72485-222-10) / 26.3 mL in 1 VIAL, SINGLE-DOSE	2020-01-15	0000-00-00	No	No	Current