Repaglinide

Product NDC: 63629-8363
Requested package NDC: 63629-8363-1
11-digit product format: 636298363
Labeler code: 63629
Product ID: 63629-8363_da1f638d-f027-4163-8496-17a8fd8ce2e6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Repaglinide
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA203820
Marketing category: ANDA
Marketing start: 2014-01-22
Marketing end: 0000-00-00
Substance: REPAGLINIDE
Active strength: 2 mg/1
Pharmacologic classes: Glinide [EPC], Potassium Channel Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-8363	63629-8363-1	D	Discontinued by firm		2026-08-10

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 · 12 matching rows.

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

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

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203820-001	REPAGLINIDE	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22
A203820-002	REPAGLINIDE	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22
A203820-003	REPAGLINIDE	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203820-001	AB
A203820-002	AB
A203820-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203820-002	REPAGLINIDE	1MG	TABLET / ORAL	AB		2014-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203820-003	REPAGLINIDE	2MG	TABLET / ORAL	AB	RS	2014-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203820-001	REPAGLINIDE	0.5MG	TABLET / ORAL	AB		2014-01-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A203820-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203820-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203820-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203820-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203820-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203820-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203820-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203820-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203820-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203820-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203820-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203820-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203820-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203820-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203820-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203820-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203820-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203820-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203820-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203820-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203820-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203820-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203820-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203820-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203820-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203820-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203820-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203820-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203820-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203820-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203820-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203820-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203820-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203820-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203820-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203820-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203820-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203820-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203820-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203820-001	AB	1	`8072bd15b7f6…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Repaglinide	REPAGLINIDE	Bryant Ranch Prepack	6ae28683-28cc-408e-90f9-6a3dddfc668d	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203820 application number: ANDA203820
Repaglinide	REPAGLINIDE	Bryant Ranch Prepack	3b150917-e2fd-4366-af83-ebc1d7297ca9	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203820 application number: ANDA203820
Repaglinide	REPAGLINIDE	American Health Packaging	dd1d8337-9903-4b8a-a9ea-569e4d134e74	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203820 application number: ANDA203820
Repaglinide	REPAGLINIDE	Aurobindo Pharma Limited	68064989-47ea-4ed5-a20e-43c4ef6ec271	2024-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203820 application number: ANDA203820
Repaglinide	REPAGLINIDE	Rising Pharma Holdings, Inc.	d7673e22-0dbb-4395-ad60-943d249203a1	2024-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203820 application number: ANDA203820

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
668Z8C33LU	REPAGLINIDE	135062-02-1	REPAGLINIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8363-1	63629836301	30 TABLET in 1 BOTTLE (63629-8363-1)	30 tablet	2020-10-16	0000-00-00	No	No	Current