Fenofibrate

Product NDC: 68180-361
11-digit product format: 681800361
Labeler code: 68180
Product ID: 68180-361_699ad4ef-4415-4637-a001-3a8ba77f39df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: TABLET
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA090856
Marketing category: ANDA
Marketing start: 2012-11-19
Marketing end: 2022-07-31
Substance: FENOFIBRATE
Active strength: 145 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 22 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	68180-361-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	68180-361-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	68180-361-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	68180-361-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	68180-361-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	68180-361-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	68180-361-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	68180-361-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	68180-361-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	68180-361-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	68180-361-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	68180-361-09	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	68180-361-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	68180-361-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	68180-361-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	68180-361-09	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	68180-361-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	68180-361-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	68180-361-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	68180-361-09	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	68180-361-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	68180-361-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090856-001	FENOFIBRATE	FENOFIBRATE	48MG	TABLET / ORAL	AB		2011-12-23
A090856-002	FENOFIBRATE	FENOFIBRATE	145MG	TABLET / ORAL	AB		2011-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090856-001	AB
A090856-002	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 3 · 82 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	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A090856-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090856-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090856-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090856-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090856-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090856-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090856-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090856-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090856-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090856-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090856-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090856-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090856-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090856-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090856-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090856-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090856-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090856-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090856-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090856-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090856-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090856-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090856-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090856-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090856-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090856-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090856-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090856-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090856-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090856-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090856-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090856-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090856-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090856-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090856-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090856-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090856-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090856-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090856-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090856-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
193bb7da-5c03-8f95-9048-23ef403846b0	Product name	3	20250616
fa35fb9a-7146-716b-13c8-bc1f60030232	Product name	9	20250114
cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07	Product name	8	20231212
53d5b6b7-785a-4500-9460-263c7f8424b8	Product name	5	20210105
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66	Product name	9	20200708
36a239c8-03fb-0083-81af-6c1afb195671	Product name	1	20140508
a0296d70-ca85-018c-84e8-cf3f630976b7	Product name	1	20140508
f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372a	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-361-02	EA - Each	68180-361	df43cfff-30f6-4bfe-945b-db7c809af1db	1	2013-02-13
68180-361-09	EA - Each	68180-361	6a85cc57-56e7-49e9-be4d-7a1a8f9e30fc	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENOFIBRATE	ACTIVE INGREDIENT	U202363UOS	FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]	4
FENOFIBRATE	ACTIVE MOIETY	U202363UOS	FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]	4
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]	4
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]	4
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]	4
FENOFIBRATE	ACTIVE INGREDIENT	U202363UOS	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
FENOFIBRATE	ACTIVE MOIETY	U202363UOS	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-361	FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.]	19	Legacy NDC	20250316_45364845-c3b4-40a1-a677-82202ffaa5ad.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Major Pharmaceuticals	d9be3ae3-6da9-47fd-bcfd-e561b9d585ca	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856
Fenofibrate	FENOFIBRATE	AvPAK	e949c068-bc7d-3038-e053-2a95a90aee00	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856
Fenofibrate	FENOFIBRATE	Northwind Health Company, LLC	0865c177-b78a-318e-e063-6394a90a318a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856
Fenofibrate	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	45364845-c3b4-40a1-a677-82202ffaa5ad	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856
Fenofibrate	FENOFIBRATE	American Health Packaging	d1f64796-6ba0-415c-a6a0-5456b21a7ed6	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856
Fenofibrate	FENOFIBRATE	Preferred Pharmaceuticals Inc.	2e6711e9-782d-46bd-9447-6612fe7d0fe7	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U202363UOS	FENOFIBRATE	49562-28-9	FENOFIBRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
477560	fenofibrate 145 MG Oral Tablet	PSN	45364845-c3b4-40a1-a677-82202ffaa5ad	22
477562	fenofibrate 48 MG Oral Tablet	PSN	45364845-c3b4-40a1-a677-82202ffaa5ad	22
477560	fenofibrate 145 MG Oral Tablet	SCD	45364845-c3b4-40a1-a677-82202ffaa5ad	22
477562	fenofibrate 48 MG Oral Tablet	SCD	45364845-c3b4-40a1-a677-82202ffaa5ad	22
477560	fenofibrate 145 MG Oral Tablet	PSN	2e82e604-feec-4ac7-ab62-28f602d4d0d1	3
477560	fenofibrate 145 MG Oral Tablet	SCD	2e82e604-feec-4ac7-ab62-28f602d4d0d1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-361-02	68180036102	500 TABLET in 1 BOTTLE (68180-361-02)	500 tablet	2012-11-19	2022-07-31	No	No	Current
68180-361-03	68180036103	1000 TABLET in 1 BOTTLE (68180-361-03)	1000 tablet	2012-11-19	2022-07-31	No	No	Current
68180-361-09	68180036109	90 TABLET in 1 BOTTLE (68180-361-09)	90 tablet	2012-11-19	2022-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fenofibrate	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2025-11-19	HUMAN PRESCRIPTION DRUG LABEL	22
Fenofibrate	American Health Packaging	2021-08-06	HUMAN PRESCRIPTION DRUG LABEL	8
Fenofibrate	AvPAK	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	4
Fenofibrate	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	3