Gemcitabine

Product NDC: 71288-117
11-digit product format: 712880117
Labeler code: 71288
Product ID: 71288-117_be3f7738-022f-4b20-94f3-40f5337997c1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gemcitabine hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Meitheal Pharmaceuticals Inc.
Application: ANDA212129
Marketing category: ANDA
Marketing start: 2020-12-11
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: 2026-12-31
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	Approval date
A212129-001	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11
A212129-002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11
A212129-003	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212129-001	AP
A212129-002	AP
A212129-003	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 · 105 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
2026-02-19 14:30 UTC	2026-02	A212129-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212129-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212129-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212129-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212129-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212129-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212129-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212129-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212129-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212129-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212129-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212129-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212129-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212129-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212129-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212129-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212129-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212129-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212129-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212129-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212129-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212129-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212129-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212129-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212129-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212129-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212129-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212129-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212129-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212129-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212129-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212129-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212129-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212129-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212129-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212129-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212129-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212129-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212129-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212129-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	2020-12-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 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	A212129-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212129-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212129-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212129-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212129-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212129-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212129-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212129-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212129-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212129-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212129-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212129-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212129-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212129-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212129-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212129-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212129-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212129-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212129-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212129-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212129-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212129-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212129-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212129-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212129-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212129-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212129-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212129-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212129-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212129-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212129-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212129-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212129-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212129-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212129-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212129-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212129-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212129-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212129-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212129-001	AP	1	`8072bd15b7f6…`

Additional Listing Data#

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

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
c0b1b715-9ff8-43ca-9e49-465f1f380084	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
71288-117-06	Gemcitabine	1 in 1 CARTON	INJECTION, SOLUTION	1	7
71288-117-06	Gemcitabine	5.26 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	5.26	7
71288-117-28	Gemcitabine	26.3 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	26.3	7
71288-117-28	Gemcitabine	1 in 1 CARTON	INJECTION, SOLUTION	1	7
71288-117-54	Gemcitabine	52.6 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	52.6	7
71288-117-54	Gemcitabine	1 in 1 CARTON	INJECTION, SOLUTION	1	7
71288-117-91	Gemcitabine	5.26 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	5.26	1
71288-117-91	Gemcitabine	1 in 1 CARTON	INJECTION, SOLUTION	1	1
71288-117-92	Gemcitabine	1 in 1 CARTON	INJECTION, SOLUTION	1	1
71288-117-92	Gemcitabine	26.3 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	26.3	1
71288-117-93	Gemcitabine	52.6 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	52.6	1
71288-117-93	Gemcitabine	1 in 1 CARTON	INJECTION, SOLUTION	1	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71288-117-06	ML - Milliliter	71288-117	d12443d0-9037-4b5c-ac20-9b9deb5eeddf	1	2021-04-08
71288-117-28	ML - Milliliter	71288-117	e76b60a2-8c90-425c-a4d3-7571ad397b8b	1	2021-04-08
71288-117-54	ML - Milliliter	71288-117	b0f07a74-b772-436e-bd1f-a70172259faa	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71288-117	GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]	7	Current NDC, Legacy NDC, 6 package rows	20240925_73ae04d8-38f9-4d3d-b0c2-71d22af1fc86.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 HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	c0b1b715-9ff8-43ca-9e49-465f1f380084	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212129 application number: ANDA212129 ndc (product): 71288-117
Gemcitabine	GEMCITABINE HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	73ae04d8-38f9-4d3d-b0c2-71d22af1fc86	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212129 application number: ANDA212129 ndc (product): 71288-117

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	73ae04d8-38f9-4d3d-b0c2-71d22af1fc86	7
1720975	gemcitabine 2 GM in 52.6 ML Injection	PSN	73ae04d8-38f9-4d3d-b0c2-71d22af1fc86	7
1720977	gemcitabine 200 MG in 5.26 ML Injection	PSN	73ae04d8-38f9-4d3d-b0c2-71d22af1fc86	7
1720960	26.3 ML gemcitabine 38 MG/ML Injection	SCD	73ae04d8-38f9-4d3d-b0c2-71d22af1fc86	7
1720977	5.26 ML gemcitabine 38 MG/ML Injection	SCD	73ae04d8-38f9-4d3d-b0c2-71d22af1fc86	7
1720975	52.6 ML gemcitabine 38 MG/ML Injection	SCD	73ae04d8-38f9-4d3d-b0c2-71d22af1fc86	7
1720960	gemcitabine (as gemcitamine HCl) 1 GM per 26.3 ML Injection	SY	73ae04d8-38f9-4d3d-b0c2-71d22af1fc86	7
1720975	gemcitabine (as gemcitamine HCl) 2 GM per 52.6 ML Injection	SY	73ae04d8-38f9-4d3d-b0c2-71d22af1fc86	7
1720977	gemcitabine (as gemcitamine HCl) 200 MG per 5.26 ML Injection	SY	73ae04d8-38f9-4d3d-b0c2-71d22af1fc86	7
1720960	gemcitabine 1 GM per 26.3 ML Injection	SY	73ae04d8-38f9-4d3d-b0c2-71d22af1fc86	7
1720975	gemcitabine 2 GM per 52.6 ML Injection	SY	73ae04d8-38f9-4d3d-b0c2-71d22af1fc86	7
1720977	gemcitabine 200 MG per 5.26 ML Injection	SY	73ae04d8-38f9-4d3d-b0c2-71d22af1fc86	7
1720960	gemcitabine 1 GM in 26.3 ML Injection	PSN	c0b1b715-9ff8-43ca-9e49-465f1f380084	1
1720975	gemcitabine 2 GM in 52.6 ML Injection	PSN	c0b1b715-9ff8-43ca-9e49-465f1f380084	1
1720977	gemcitabine 200 MG in 5.26 ML Injection	PSN	c0b1b715-9ff8-43ca-9e49-465f1f380084	1
1720960	26.3 ML gemcitabine 38 MG/ML Injection	SCD	c0b1b715-9ff8-43ca-9e49-465f1f380084	1
1720977	5.26 ML gemcitabine 38 MG/ML Injection	SCD	c0b1b715-9ff8-43ca-9e49-465f1f380084	1
1720975	52.6 ML gemcitabine 38 MG/ML Injection	SCD	c0b1b715-9ff8-43ca-9e49-465f1f380084	1
1720960	gemcitabine (as gemcitamine HCl) 1 GM per 26.3 ML Injection	SY	c0b1b715-9ff8-43ca-9e49-465f1f380084	1
1720975	gemcitabine (as gemcitamine HCl) 2 GM per 52.6 ML Injection	SY	c0b1b715-9ff8-43ca-9e49-465f1f380084	1
1720977	gemcitabine (as gemcitamine HCl) 200 MG per 5.26 ML Injection	SY	c0b1b715-9ff8-43ca-9e49-465f1f380084	1
1720960	gemcitabine 1 GM per 26.3 ML Injection	SY	c0b1b715-9ff8-43ca-9e49-465f1f380084	1
1720975	gemcitabine 2 GM per 52.6 ML Injection	SY	c0b1b715-9ff8-43ca-9e49-465f1f380084	1
1720977	gemcitabine 200 MG per 5.26 ML Injection	SY	c0b1b715-9ff8-43ca-9e49-465f1f380084	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71288-117-06	71288011706	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-06) / 5.26 mL in 1 VIAL, SINGLE-DOSE	2020-12-11	0000-00-00	No	No	Current
71288-117-28	71288011728	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-28) / 26.3 mL in 1 VIAL, SINGLE-DOSE	2020-12-11	0000-00-00	No	No	Current
71288-117-54	71288011754	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-54) / 52.6 mL in 1 VIAL, SINGLE-DOSE	2020-12-11	0000-00-00	No	No	Current
71288-117-91	71288011791	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-91) / 5.26 mL in 1 VIAL, SINGLE-DOSE	2020-12-11		No	No	Current
71288-117-92	71288011792	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-92) / 26.3 mL in 1 VIAL, SINGLE-DOSE	2020-12-11		No	No	Current
71288-117-93	71288011793	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-93) / 52.6 mL in 1 VIAL, SINGLE-DOSE	2020-12-11		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gemcitabine	Meitheal Pharmaceuticals Inc.	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	1
Gemcitabine	Meitheal Pharmaceuticals Inc.	2024-08-05	HUMAN PRESCRIPTION DRUG LABEL	7