Repaglinide

Product NDC: 57237-158
11-digit product format: 572370158
Labeler code: 57237
Product ID: 57237-158_641cf1c4-6d24-4ad7-b85a-b2ddbb9263c4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Repaglinide
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA203820
Marketing category: ANDA
Marketing start: 2014-01-22
Substance: REPAGLINIDE
Active strength: 1 mg/1
Pharmacologic classes: Glinide [EPC], Potassium Channel Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Repaglinide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
REPAGLINIDE	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
668Z8C33LU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200256	Internal RxNorm lookup
200257	Internal RxNorm lookup
200258	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d7673e22-0dbb-4395-ad60-943d249203a1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ea03026f-270e-3aaa-c14e-f7103b55f75b	Product name	3	20240321
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57237-158-01	Repaglinide	100 in 1 BOTTLE	TABLET	100		7
57237-158-05	Repaglinide	500 in 1 BOTTLE	TABLET	500		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-158-01	EA - Each	57237-158	97e1f8bf-5978-4317-8a87-297a8d0edf41	1	2016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
REPAGLINIDE	ACTIVE INGREDIENT	668Z8C33LU	REPAGLINIDE TABLET [CITRON PHARMA LLC]	1
REPAGLINIDE	ACTIVE MOIETY	668Z8C33LU	REPAGLINIDE TABLET [CITRON PHARMA LLC]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	REPAGLINIDE TABLET [CITRON PHARMA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	REPAGLINIDE TABLET [CITRON PHARMA LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	REPAGLINIDE TABLET [CITRON PHARMA LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	REPAGLINIDE TABLET [CITRON PHARMA LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	REPAGLINIDE TABLET [CITRON PHARMA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	REPAGLINIDE TABLET [CITRON PHARMA LLC]	1
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	REPAGLINIDE TABLET [CITRON PHARMA LLC]	1
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	REPAGLINIDE TABLET [CITRON PHARMA LLC]	1
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	REPAGLINIDE TABLET [CITRON PHARMA LLC]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	REPAGLINIDE TABLET [CITRON PHARMA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	REPAGLINIDE TABLET [CITRON PHARMA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-158	REPAGLINIDE TABLET [RISING PHARMA HOLDINGS, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20240524_d7673e22-0dbb-4395-ad60-943d249203a1.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 · 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 ndc (product): 57237-158

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200257	repaglinide 0.5 MG Oral Tablet	PSN	d7673e22-0dbb-4395-ad60-943d249203a1	7
200256	repaglinide 1 MG Oral Tablet	PSN	d7673e22-0dbb-4395-ad60-943d249203a1	7
200258	repaglinide 2 MG Oral Tablet	PSN	d7673e22-0dbb-4395-ad60-943d249203a1	7
200257	repaglinide 0.5 MG Oral Tablet	SCD	d7673e22-0dbb-4395-ad60-943d249203a1	7
200256	repaglinide 1 MG Oral Tablet	SCD	d7673e22-0dbb-4395-ad60-943d249203a1	7
200258	repaglinide 2 MG Oral Tablet	SCD	d7673e22-0dbb-4395-ad60-943d249203a1	7
200256	repaglinide 1 MG Oral Tablet	PSN	dd1d8337-9903-4b8a-a9ea-569e4d134e74	4
200256	repaglinide 1 MG Oral Tablet	SCD	dd1d8337-9903-4b8a-a9ea-569e4d134e74	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-158-01	57237015801	100 TABLET in 1 BOTTLE (57237-158-01)	100 tablet	2014-01-22	0000-00-00	No	No	Current
57237-158-05	57237015805	500 TABLET in 1 BOTTLE (57237-158-05)	500 tablet	2014-01-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Repaglinide	American Health Packaging	2024-10-22	HUMAN PRESCRIPTION DRUG LABEL	4
Repaglinide	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-05-14	Human Prescription Drug Label	7