GEMCITABINE

Product NDC: 68001-348
11-digit product format: 680010348
Labeler code: 68001
Product ID: 68001-348_830c5aa5-79d2-4342-9d53-070bfd7ab05c
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
Marketing end: 0000-00-00
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: 2020-12-31
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	68001-348		D	Discontinued by firm		2026-10-23
excluded package	package	68001-348	68001-348-36	D	Discontinued by firm		2026-10-23

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N209604-001	GEMCITABINE HYDROCHLORIDE	200MG/2ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-08-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209604-002	GEMCITABINE HYDROCHLORIDE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-08-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209604-003	GEMCITABINE HYDROCHLORIDE	1.5GM/15ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-08-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209604-004	GEMCITABINE HYDROCHLORIDE	2GM/20ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-08-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209604-001	GEMCITABINE HYDROCHLORIDE	200MG/2ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209604-002	GEMCITABINE HYDROCHLORIDE	1GM/10ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209604-003	GEMCITABINE HYDROCHLORIDE	1.5GM/15ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209604-004	GEMCITABINE HYDROCHLORIDE	2GM/20ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-08-03	`84e616aacf4f…`
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…`

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
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	Legacy NDC, 2 package rows	20230912_4031017d-d768-46de-8081-476bcb883f5e.zip

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