GEMCITABINE

Product NDC: 68001-348
11-digit product format: 680010348
Labeler code: 68001
Product ID: 68001-348_049982fe-a321-b868-e063-6294a90ae861
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GEMCITABINE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: BluePoint Laboratories
Application: NDA209604
Marketing category: NDA
Marketing start: 2018-05-25
Substance: GEMCITABINE HYDROCHLORIDE
Active strength: 100 mg/mL
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

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N209604-001	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	200MG/2ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-08-03
N209604-002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-08-03
N209604-003	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	1.5GM/15ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-08-03
N209604-004	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	2GM/20ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-08-03

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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209604-001	GEMCITABINE HYDROCHLORIDE	200MG/2ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209604-002	GEMCITABINE HYDROCHLORIDE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209604-003	GEMCITABINE HYDROCHLORIDE	1.5GM/15ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209604-004	GEMCITABINE HYDROCHLORIDE	2GM/20ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209604-001	GEMCITABINE HYDROCHLORIDE	200MG/2ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209604-002	GEMCITABINE HYDROCHLORIDE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209604-003	GEMCITABINE HYDROCHLORIDE	1.5GM/15ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209604-004	GEMCITABINE HYDROCHLORIDE	2GM/20ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209604-001	GEMCITABINE HYDROCHLORIDE	200MG/2ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209604-002	GEMCITABINE HYDROCHLORIDE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209604-003	GEMCITABINE HYDROCHLORIDE	1.5GM/15ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209604-004	GEMCITABINE HYDROCHLORIDE	2GM/20ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209604-001	GEMCITABINE HYDROCHLORIDE	200MG/2ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209604-002	GEMCITABINE HYDROCHLORIDE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209604-003	GEMCITABINE HYDROCHLORIDE	1.5GM/15ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209604-004	GEMCITABINE HYDROCHLORIDE	2GM/20ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209604-001	GEMCITABINE HYDROCHLORIDE	200MG/2ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209604-002	GEMCITABINE HYDROCHLORIDE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209604-003	GEMCITABINE HYDROCHLORIDE	1.5GM/15ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209604-004	GEMCITABINE HYDROCHLORIDE	2GM/20ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209604-001	GEMCITABINE HYDROCHLORIDE	200MG/2ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209604-002	GEMCITABINE HYDROCHLORIDE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209604-003	GEMCITABINE HYDROCHLORIDE	1.5GM/15ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209604-004	GEMCITABINE HYDROCHLORIDE	2GM/20ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209604-001	GEMCITABINE HYDROCHLORIDE	200MG/2ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209604-002	GEMCITABINE HYDROCHLORIDE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209604-003	GEMCITABINE HYDROCHLORIDE	1.5GM/15ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209604-004	GEMCITABINE HYDROCHLORIDE	2GM/20ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209604-001	GEMCITABINE HYDROCHLORIDE	200MG/2ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209604-002	GEMCITABINE HYDROCHLORIDE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209604-003	GEMCITABINE HYDROCHLORIDE	1.5GM/15ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209604-004	GEMCITABINE HYDROCHLORIDE	2GM/20ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209604-001	GEMCITABINE HYDROCHLORIDE	200MG/2ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209604-002	GEMCITABINE HYDROCHLORIDE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209604-003	GEMCITABINE HYDROCHLORIDE	1.5GM/15ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209604-004	GEMCITABINE HYDROCHLORIDE	2GM/20ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209604-001	GEMCITABINE HYDROCHLORIDE	200MG/2ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209604-002	GEMCITABINE HYDROCHLORIDE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209604-003	GEMCITABINE HYDROCHLORIDE	1.5GM/15ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209604-004	GEMCITABINE HYDROCHLORIDE	2GM/20ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-08-03	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: GEMCITABINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GEMCITABINE HYDROCHLORIDE	100 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1998783	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
4031017d-d768-46de-8081-476bcb883f5e	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	Strength	SPL version
68001-348-36	GEMCITABINE	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10		5
68001-348-36	GEMCITABINE	1 in 1 CARTON	INJECTION, SOLUTION	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-348-36	ML - Milliliter	68001-348	6faff9a3-4798-401c-a62e-54ef1a6bf66e	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-348	GEMCITABINE INJECTION, SOLUTION [BLUEPOINT LABORATORIES]	5	Current NDC, Legacy NDC, 2 package rows	20230912_4031017d-d768-46de-8081-476bcb883f5e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GEMCITABINE	GEMCITABINE	BluePoint Laboratories	4031017d-d768-46de-8081-476bcb883f5e	2023-09-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209604 application number: NDA209604 ndc (product): 68001-348

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
1998783	gemcitabine 100 MG/mL Injectable Solution	PSN	4031017d-d768-46de-8081-476bcb883f5e	5
1998783	gemcitabine 100 MG/ML Injectable Solution	SCD	4031017d-d768-46de-8081-476bcb883f5e	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-348-36	68001034836	1 VIAL, MULTI-DOSE in 1 CARTON (68001-348-36) / 10 mL in 1 VIAL, MULTI-DOSE	2018-05-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GEMCITABINE	BluePoint Laboratories \| Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2023-09-11	HUMAN PRESCRIPTION DRUG LABEL	5