Starlix

Product NDC: 0078-0351
11-digit product format: 000780351
Labeler code: 0078
Product ID: 0078-0351_7b6f4dc4-ada4-47b5-bf49-af85910ccfaf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nateglinide
Dosage form: TABLET
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA021204
Marketing category: NDA
Marketing start: 2000-12-04
Marketing end: 2021-09-30
Substance: NATEGLINIDE
Active strength: 60 mg/1
Pharmacologic classes: Glinide [EPC],Potassium Channel Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	0078-0351		D	Discontinued by firm		2026-08-17
excluded package	package	0078-0351	0078-0351-05	D	Discontinued by firm		2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0078-0351-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0078-0351-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0078-0351-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0078-0351-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0078-0351-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0078-0351-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0078-0351-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0078-0351-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0078-0351-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0078-0351-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0078-0351-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0078-0351-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021204-001	STARLIX	NATEGLINIDE	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-12-22
N021204-002	STARLIX	NATEGLINIDE	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-12-22

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021204-001	STARLIX	60MG	TABLET / ORAL	RLD	2000-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021204-002	STARLIX	120MG	TABLET / ORAL	RLD	2000-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021204-001	STARLIX	60MG	TABLET / ORAL	RLD	2000-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021204-002	STARLIX	120MG	TABLET / ORAL	RLD	2000-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021204-001	STARLIX	60MG	TABLET / ORAL	RLD	2000-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021204-002	STARLIX	120MG	TABLET / ORAL	RLD	2000-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021204-001	STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021204-002	STARLIX	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2000-12-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	N021204-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021204-002	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0351-05	EA - Each	0078-0351	ff9f5d66-2d9b-4222-8c5d-647ebaffbd51	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NATEGLINIDE	ACTIVE INGREDIENT	41X3PWK4O2	STARLIX (NATEGLINIDE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	6
NATEGLINIDE	ACTIVE MOIETY	41X3PWK4O2	STARLIX (NATEGLINIDE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	STARLIX (NATEGLINIDE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	STARLIX (NATEGLINIDE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	STARLIX (NATEGLINIDE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	STARLIX (NATEGLINIDE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	6
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	STARLIX (NATEGLINIDE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	STARLIX (NATEGLINIDE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	STARLIX (NATEGLINIDE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	STARLIX (NATEGLINIDE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	6
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	STARLIX (NATEGLINIDE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	STARLIX (NATEGLINIDE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	STARLIX (NATEGLINIDE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	STARLIX (NATEGLINIDE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	6

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
41X3PWK4O2	NATEGLINIDE	105816-04-4	NATEGLINIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0351-05	00078035105	100 TABLET in 1 BOTTLE (0078-0351-05)	100 tablet	2000-12-04	2021-09-30	No	No	Current