Gemcitabine

Product NDC: 0409-0182
11-digit product format: 004090182
Labeler code: 0409
Product ID: 0409-0182_3a284abb-8c57-47dc-a138-5a6e6ab92b05
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GEMCITABINE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: NDA200795
Marketing category: NDA
Marketing start: 2011-08-22
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	RLD / RS	Approval date
N200795-001	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04
N200795-002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04
N200795-003	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N200795-001	AP
N200795-002	AP
N200795-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N200795-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200795-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200795-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200795-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200795-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200795-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200795-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200795-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200795-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200795-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200795-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200795-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200795-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200795-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200795-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200795-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200795-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200795-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200795-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200795-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200795-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200795-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200795-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200795-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200795-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200795-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200795-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200795-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200795-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200795-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200795-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200795-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200795-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200795-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200795-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200795-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200795-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200795-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200795-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200795-001	AP	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GEMCITABINE HYDROCHLORIDE	38 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U347PV74IL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1720960	Internal RxNorm lookup
1720975	Internal RxNorm lookup
1720977	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
dc02a23b-3ff9-4441-aa91-8e9e629a7315	Available on FDA.report

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	SPL version
0409-0182-01	Gemcitabine	52.6 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	52.6	28
0409-0182-01	Gemcitabine	1 in 1 CARTON	INJECTION, SOLUTION	1	28
0409-0182-25	Gemcitabine	52.6 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	52.6	10
0409-0182-25	Gemcitabine	1 in 1 CARTON	INJECTION, SOLUTION	1	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-0182-01	ML - Milliliter	0409-0182	12a05c17-1e05-477f-83e7-53119f386a7c	1	2012-07-24
0409-0182-25	ML - Milliliter	0409-0182	dedb48b0-d2e5-4d73-80a5-16b30d418020	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GEMCITABINE HYDROCHLORIDE	ACTIVE INGREDIENT	U347PV74IL	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]	13
GEMCITABINE	ACTIVE MOIETY	B76N6SBZ8R	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]	13
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]	13
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]	13
WATER	INACTIVE INGREDIENT	059QF0KO0R	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]	13
GEMCITABINE HYDROCHLORIDE	ACTIVE INGREDIENT	U347PV74IL	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]	2
GEMCITABINE	ACTIVE MOIETY	B76N6SBZ8R	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-0182	GEMCITABINE INJECTION, SOLUTION [HOSPIRA, INC.]	25	Current NDC, Legacy NDC, 2 package rows	20250121_dc02a23b-3ff9-4441-aa91-8e9e629a7315.zip
0409-0182	GEMCITABINE INJECTION, SOLUTION [HOSPIRA, INC.]	9	Current NDC, Legacy NDC, 2 package rows	20240710_e18ed1cb-7dd0-4001-bfda-17d1f4587fb8.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemcitabine	GEMCITABINE	Hospira, Inc.	dc02a23b-3ff9-4441-aa91-8e9e629a7315	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 200795 application number: NDA200795 ndc (product): 0409-0182
Gemcitabine	GEMCITABINE	Hospira, Inc.	e18ed1cb-7dd0-4001-bfda-17d1f4587fb8	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 200795 application number: NDA200795 ndc (product): 0409-0182

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

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	dc02a23b-3ff9-4441-aa91-8e9e629a7315	28
1720975	gemcitabine 2 GM in 52.6 ML Injection	PSN	dc02a23b-3ff9-4441-aa91-8e9e629a7315	28
1720977	gemcitabine 200 MG in 5.26 ML Injection	PSN	dc02a23b-3ff9-4441-aa91-8e9e629a7315	28
1720960	26.3 ML gemcitabine 38 MG/ML Injection	SCD	dc02a23b-3ff9-4441-aa91-8e9e629a7315	28
1720977	5.26 ML gemcitabine 38 MG/ML Injection	SCD	dc02a23b-3ff9-4441-aa91-8e9e629a7315	28
1720975	52.6 ML gemcitabine 38 MG/ML Injection	SCD	dc02a23b-3ff9-4441-aa91-8e9e629a7315	28
1720960	gemcitabine (as gemcitamine HCl) 1 GM per 26.3 ML Injection	SY	dc02a23b-3ff9-4441-aa91-8e9e629a7315	28
1720975	gemcitabine (as gemcitamine HCl) 2 GM per 52.6 ML Injection	SY	dc02a23b-3ff9-4441-aa91-8e9e629a7315	28
1720977	gemcitabine (as gemcitamine HCl) 200 MG per 5.26 ML Injection	SY	dc02a23b-3ff9-4441-aa91-8e9e629a7315	28
1720960	gemcitabine 1 GM per 26.3 ML Injection	SY	dc02a23b-3ff9-4441-aa91-8e9e629a7315	28
1720975	gemcitabine 2 GM per 52.6 ML Injection	SY	dc02a23b-3ff9-4441-aa91-8e9e629a7315	28
1720977	gemcitabine 200 MG per 5.26 ML Injection	SY	dc02a23b-3ff9-4441-aa91-8e9e629a7315	28

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-0182-01	00409018201	1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0182-01) / 52.6 mL in 1 VIAL, SINGLE-DOSE	2011-08-22	0000-00-00	No	No	Current
0409-0182-25	00409018225	1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0182-25) / 52.6 mL in 1 VIAL, SINGLE-DOSE	2013-07-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gemcitabine	Hospira, Inc. \| Zydus Hospira Oncology Private Limited	2026-04-27	HUMAN PRESCRIPTION DRUG LABEL	28
Gemcitabine	Hospira, Inc. \| Zydus Hospira Oncology Private Limited	2026-04-27	HUMAN PRESCRIPTION DRUG LABEL	11