NATEGLINIDE

Product NDC: 75834-205
11-digit product format: 758340205
Labeler code: 75834
Product ID: 75834-205_4b5b12e1-59db-4ec2-a2be-9b60abc79ebf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NATEGLINIDE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Nivagen Pharmaceuticals, Inc.
Application: ANDA206432
Marketing category: ANDA
Marketing start: 2019-09-25
Marketing end: 0000-00-00
Substance: NATEGLINIDE
Active strength: 60 mg/1
Pharmacologic classes: Glinide [EPC],Potassium Channel Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	75834-205		D	Discontinued by firm		2026-09-14
excluded package	package	75834-205	75834-205-01	D	Discontinued by firm		2026-09-14

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

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
A206432-001	NATEGLINIDE	NATEGLINIDE	60MG	TABLET / ORAL	AB		2019-04-19
A206432-002	NATEGLINIDE	NATEGLINIDE	120MG	TABLET / ORAL	AB		2019-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206432-001	AB
A206432-002	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 · 86 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	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206432-001	NATEGLINIDE	60MG	TABLET / ORAL	AB	2019-04-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206432-002	NATEGLINIDE	120MG	TABLET / ORAL	AB	2019-04-19	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A206432-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206432-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206432-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206432-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206432-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206432-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206432-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206432-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206432-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206432-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206432-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206432-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206432-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206432-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206432-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206432-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206432-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206432-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206432-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206432-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206432-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206432-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206432-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206432-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206432-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206432-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206432-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206432-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206432-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206432-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206432-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206432-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206432-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206432-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206432-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206432-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206432-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206432-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206432-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206432-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
1a9c08ff-3275-8942-ea88-fa08fe78716c	Product name	5	20190711
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75834-205-01	NATEGLINIDE	100 in 1 BOTTLE	TABLET, COATED	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75834-205-01	EA - Each	75834-205	f13dd54a-0cca-4380-8a3c-54574da4cd20	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75834-205	NATEGLINIDE TABLET, COATED [NIVAGEN PHARMACEUTICALS, INC.]	2	Legacy NDC, 1 package rows	20210116_21b211b5-cc92-490f-9903-42fff6a946cd.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
Nateglinide	NATEGLINIDE	Cadila Pharmaceuticals Limited	c678b772-acba-4b59-a0b2-d70d84283425	2022-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206432 application number: ANDA206432
Nateglinide	NATEGLINIDE	Modavar Pharmaceuticals LLC	af81465b-5f49-4eeb-8122-ef7fe5d90ddc	2021-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206432 application number: ANDA206432

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311919	nateglinide 120 MG Oral Tablet	PSN	21b211b5-cc92-490f-9903-42fff6a946cd	2
314142	nateglinide 60 MG Oral Tablet	PSN	21b211b5-cc92-490f-9903-42fff6a946cd	2
311919	nateglinide 120 MG Oral Tablet	SCD	21b211b5-cc92-490f-9903-42fff6a946cd	2
314142	nateglinide 60 MG Oral Tablet	SCD	21b211b5-cc92-490f-9903-42fff6a946cd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
75834-205-01	75834020501	100 TABLET, COATED in 1 BOTTLE (75834-205-01)	2019-09-25	0000-00-00	No	No	Current