Gemfibrozil

Product NDC: 16714-101
11-digit product format: 167140101
Labeler code: 16714
Product ID: 16714-101_ff9c9bd0-e2a2-4e38-aa8b-16d215d36450
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gemfibrozil
Dosage form: TABLET
Route: ORAL
Labeler: Northstar RxLLC
Application: ANDA079072
Marketing category: ANDA
Marketing start: 2010-12-20
Marketing end: 2026-12-31
Substance: GEMFIBROZIL
Active strength: 600 mg/1
Pharmacologic classes: Fibric Acids [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
NDC exclude flag: No
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079072-001	GEMFIBROZIL	GEMFIBROZIL	600MG	TABLET / ORAL	AB		2010-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079072-001	AB

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 2 · 41 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	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079072-001	GEMFIBROZIL	600MG	TABLET / ORAL	AB	2010-09-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A079072-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079072-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079072-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079072-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079072-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079072-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079072-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079072-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079072-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079072-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079072-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079072-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079072-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079072-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079072-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079072-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079072-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079072-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079072-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079072-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079072-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079072-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079072-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079072-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079072-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079072-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079072-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079072-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079072-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079072-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079072-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079072-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079072-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079072-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079072-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079072-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079072-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079072-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079072-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079072-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Gemfibrozil

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GEMFIBROZIL	600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q8X02027X3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310459	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
75cac02c-56e3-4dfe-b1e2-4ce166b28833	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
931dfe50-414f-e1ab-9c88-b15c4ba31929	Product name	5	20210615

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16714-101-02	Gemfibrozil	60 in 1 BOTTLE	TABLET	60		25
16714-101-05	Gemfibrozil	500 in 1 BOTTLE	TABLET	500		25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-101-02	EA - Each	16714-101	75e68a39-a906-495c-b663-b1d24bf81344	1	2012-07-24
16714-101-05	EA - Each	16714-101	6d6ed0f6-38a1-4b4e-b2ce-c512a61e2c96	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GEMFIBROZIL	ACTIVE INGREDIENT	Q8X02027X3	GEMFIBROZIL TABLET [NORTHSTAR RXLLC]	15
GEMFIBROZIL	ACTIVE MOIETY	Q8X02027X3	GEMFIBROZIL TABLET [NORTHSTAR RXLLC]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GEMFIBROZIL TABLET [NORTHSTAR RXLLC]	15
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	GEMFIBROZIL TABLET [NORTHSTAR RXLLC]	15
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	GEMFIBROZIL TABLET [NORTHSTAR RXLLC]	15
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	GEMFIBROZIL TABLET [NORTHSTAR RXLLC]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GEMFIBROZIL TABLET [NORTHSTAR RXLLC]	15
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GEMFIBROZIL TABLET [NORTHSTAR RXLLC]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GEMFIBROZIL TABLET [NORTHSTAR RXLLC]	15
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GEMFIBROZIL TABLET [NORTHSTAR RXLLC]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GEMFIBROZIL TABLET [NORTHSTAR RXLLC]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GEMFIBROZIL TABLET [NORTHSTAR RXLLC]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-101	GEMFIBROZIL TABLET [NORTHSTAR RXLLC]	24	Current NDC, Legacy NDC, 2 package rows	20240731_75cac02c-56e3-4dfe-b1e2-4ce166b28833.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemfibrozil	GEMFIBROZIL	Northstar RxLLC	75cac02c-56e3-4dfe-b1e2-4ce166b28833	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079072 application number: ANDA079072 ndc (product): 16714-101
Gemfibrozil	GEMFIBROZIL	A-S Medication Solutions	5738f713-d4b4-437c-b931-fb3b2c22f6d3	2023-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079072 application number: ANDA079072
Gemfibrozil	GEMFIBROZIL	A-S Medication Solutions	4907bbfa-27f4-4569-8957-9704f9c998a0	2023-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079072 application number: ANDA079072

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q8X02027X3	GEMFIBROZIL	25812-30-0	GEMFIBROZIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310459	gemfibrozil 600 MG Oral Tablet	PSN	75cac02c-56e3-4dfe-b1e2-4ce166b28833	25
310459	gemfibrozil 600 MG Oral Tablet	SCD	75cac02c-56e3-4dfe-b1e2-4ce166b28833	25
310459	gemfibrozil 600 MG Oral Tablet	PSN	c3542eba-3c1d-57ba-e053-2995a90a517b	24
310459	gemfibrozil 600 MG Oral Tablet	SCD	c3542eba-3c1d-57ba-e053-2995a90a517b	24
310459	gemfibrozil 600 MG Oral Tablet	PSN	325afd72-9176-4a08-8383-58cecb35196d	5
310459	gemfibrozil 600 MG Oral Tablet	SCD	325afd72-9176-4a08-8383-58cecb35196d	5
310459	gemfibrozil 600 MG Oral Tablet	PSN	4907bbfa-27f4-4569-8957-9704f9c998a0	1
310459	gemfibrozil 600 MG Oral Tablet	PSN	5738f713-d4b4-437c-b931-fb3b2c22f6d3	1
310459	gemfibrozil 600 MG Oral Tablet	SCD	4907bbfa-27f4-4569-8957-9704f9c998a0	1
310459	gemfibrozil 600 MG Oral Tablet	SCD	5738f713-d4b4-437c-b931-fb3b2c22f6d3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-101-02	16714010102	60 TABLET in 1 BOTTLE (16714-101-02)	60 tablet	2010-12-20	2026-11-30	No	No	Current
16714-101-05	16714010105	500 TABLET in 1 BOTTLE (16714-101-05)	500 tablet	2010-12-20	2026-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rx Only	Northstar RxLLC \| Piramal Pharma Limited	2026-04-10	Human Prescription Drug Label	25
Rx Only	Bryant Ranch Prepack	2024-09-05	HUMAN PRESCRIPTION DRUG LABEL	5
Rx Only	A-S Medication Solutions	2023-12-18	Human Prescription Drug Label	1
Rx Only	A-S Medication Solutions	2023-12-18	Human Prescription Drug Label	1
Rx Only	NuCare Pharmaceuticals,Inc.	2021-05-27	HUMAN PRESCRIPTION DRUG LABEL	24