National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 01:22:24

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-125-53	EA - Each	63323-125	2534cd3c-11e5-4e5d-a45f-2cf6592377f8	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63323-125	63323-125-53

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090799-001	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25
A090799-002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25
A090799-003	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090799-001	AP
A090799-002	AP
A090799-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090799-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090799-003	GEMCITABINE HYDROCHLORIDE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090799-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090799-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090799-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090799-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090799-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090799-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090799-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090799-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090799-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090799-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090799-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090799-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090799-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090799-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090799-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090799-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090799-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090799-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090799-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090799-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090799-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090799-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090799-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090799-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090799-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090799-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090799-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090799-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090799-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090799-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090799-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090799-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090799-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090799-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090799-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090799-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090799-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090799-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090799-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090799-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090799-001	AP	1	`301d65b070ca…`

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	Fresenius Kabi USA, LLC	c550dd16-a5e8-44be-87f2-210c15bbb513	2024-10-14	Warnings, Adverse reactions	Exact identifier ndc (package): 63323-125-53 ndc11 (package): 63323012553

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.