Repaglinide and Metformin Hydrochloride

Product NDC: 68180-490
11-digit product format: 681800490
Labeler code: 68180
Product ID: 68180-490_acd637a1-d43a-40da-90aa-247fe927e05a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Repaglinide and Metformin Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA200624
Marketing category: ANDA
Marketing start: 2015-12-10
Marketing end: 0000-00-00
Substance: METFORMIN HYDROCHLORIDE; REPAGLINIDE
Active strength: 500 mg/1; mg/1
Pharmacologic classes: Biguanide [EPC],Biguanides [CS],Glinide [EPC],Potassium Channel Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68180-490		D	Discontinued by firm	2026-10-16
excluded package	package	68180-490	68180-490-01	D	Discontinued by firm	2026-10-16
excluded package	package	68180-490	68180-490-02	D	Discontinued by firm	2026-10-16
excluded package	package	68180-490	68180-490-03	D	Discontinued by firm	2026-10-16

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 · 48 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	68180-490-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68180-490-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68180-490-02	`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	68180-490-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68180-490-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68180-490-02	`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	68180-490-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68180-490-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68180-490-02	`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	68180-490-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68180-490-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68180-490-02	`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	68180-490-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68180-490-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68180-490-02	`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	68180-490-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68180-490-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68180-490-02	`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	68180-490-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68180-490-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68180-490-02	`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	68180-490-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68180-490-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68180-490-02	`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	68180-490-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68180-490-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68180-490-02	`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	68180-490-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68180-490-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68180-490-02	`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	68180-490-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68180-490-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68180-490-02	`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	68180-490-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68180-490-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68180-490-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; REPAGLINIDE	500MG;1MG	TABLET / ORAL			2015-07-15
A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; REPAGLINIDE	500MG;2MG	TABLET / ORAL			2015-07-15

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200624-001	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;1MG	TABLET / ORAL	2015-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200624-002	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	500MG;2MG	TABLET / ORAL	2015-07-15	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-490-01	EA - Each	68180-490	2041f2d1-374a-4797-b9f0-07f3058aa304	1	2016-01-13

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE
668Z8C33LU	REPAGLINIDE	135062-02-1	REPAGLINIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Repaglinide and Metformin Hydrochloride	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2018-03-01	HUMAN PRESCRIPTION DRUG LABEL	4