Application 077557

Type: ANDA
Sponsor: SUN PHARM INDS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONDANSETRON	ONDANSETRON	TABLET, ORALLY DISINTEGRATING;ORAL	4MG	No	No
002	ONDANSETRON	ONDANSETRON	TABLET, ORALLY DISINTEGRATING;ORAL	8MG	No	No

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
A077557-001	ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2007-08-02
A077557-002	ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2007-08-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077557-001	AB
A077557-002	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	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077557-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077557-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-08-02	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A077557-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077557-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077557-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077557-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077557-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077557-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077557-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077557-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077557-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077557-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077557-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077557-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077557-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077557-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077557-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077557-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077557-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077557-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077557-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077557-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077557-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077557-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077557-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077557-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077557-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077557-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077557-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077557-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077557-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077557-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077557-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077557-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077557-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077557-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077557-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077557-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077557-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077557-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077557-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077557-002	AB	1	`f41ea6bd6efb…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ondansetron	ONDANSETRON	Cardinal Health 107, LLC	26aff90c-49ea-46ac-bbf3-c188c2b061c9	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557 ndc (product): 55154-4567
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	92c758a3-e749-4a15-be4b-ee30b364b2b0	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557 ndc (product): 62756-240 ndc (product): 62756-356
ONDANSETRON	ONDANSETRON	Bryant Ranch Prepack	384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557 ndc (product): 63629-4306
ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	b297c163-2052-cb22-e053-2995a90a8289	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557 ndc (product): 68071-2284
ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	a1dd7420-dd81-2c8e-e053-2995a90ac8e6	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557 ndc (product): 68071-5230
ONDANSETRON	ONDANSETRON	Proficient Rx LP	4feb4b89-2d2f-4a9c-a4f4-5ae3e26281b6	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557 ndc (product): 63187-693
ONDANSETRON	ONDANSETRON	Proficient Rx LP	9913ed0c-aaad-45e1-b522-98ad170c2e8a	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077557 application number: ANDA077557 ndc (product): 63187-670

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42254-077	ONDANSETRON	ONDANSETRON	Rebel Distributors Corp	ANDA	Current
42254-097	ONDANSETRON	ONDANSETRON	Rebel Distributors Corp	ANDA	Current
50090-2103	ondansetron	ondansetron	A-S Medication Solutions	ANDA	Current
50090-2104	ondansetron	ondansetron	A-S Medication Solutions	ANDA	Current
50090-5346	ondansetron	ondansetron	A-S Medication Solutions	ANDA	Current
50090-5346	ondansetron	ondansetron	A-S Medication Solutions	ANDA	Current
50090-5346	ondansetron	ondansetron	A-S Medication Solutions	ANDA	Current
50436-0133	ondansetron	ondansetron	Unit Dose Services	ANDA	Current
53217-360	ondansetron	ondansetron	Aidarex Pharmaceuticals LLC	ANDA	Current
55154-4567	ondansetron	ondansetron	Cardinal Health 107, LLC	ANDA	Current
55154-4567	ondansetron	ondansetron	Cardinal Health	ANDA	Current
55154-4567	ondansetron	ondansetron	Cardinal Health	ANDA	Current
60760-313	ondansetron	ondansetron	St. Mary's Medical Park Pharmacy	ANDA	Current
62756-240	ondansetron	ondansetron	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-240	ondansetron	ondansetron	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-240	ondansetron	ondansetron	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-356	ondansetron	ondansetron	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-356	ondansetron	ondansetron	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-356	ondansetron	ondansetron	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63187-670	ONDANSETRON	ONDANSETRON	Proficient Rx LP	ANDA	Current
63187-670	ONDANSETRON	ONDANSETRON	Proficient Rx LP	ANDA	Current
63187-693	ONDANSETRON	ONDANSETRON	Proficient Rx LP	ANDA	Current
63187-693	ONDANSETRON	ONDANSETRON	Proficient Rx LP	ANDA	Current
63187-693	ONDANSETRON	ONDANSETRON	Proficient Rx LP	ANDA	Current
63187-693	ONDANSETRON	ONDANSETRON	Proficient Rx LP	ANDA	Current
63629-4306	ONDANSETRON	ondansetron	Bryant Ranch Prepack	ANDA	Current
63629-4306	ONDANSETRON	ondansetron	Bryant Ranch Prepack	ANDA	Current
68071-1968	ONDANSETRON	ONDANSETRON	NuCare Pharmaceutical, Inc.	ANDA	Current
68071-1977	ONDANSETRON	ONDANSETRON	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2284	ondansetron	ondansetron	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2284	ondansetron	ondansetron	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2652	ONDANSETRON	ONDANSETRON	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5230	ondansetron	ondansetron	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5230	ondansetron	ondansetron	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7705	ondansetron	ondansetron	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7705	ondansetron	ondansetron	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0042	ONDANSETRON	ONDANSETRON	REMEDYREPACK INC.	ANDA	Current
70518-0042	ONDANSETRON	ONDANSETRON	REMEDYREPACK INC.	ANDA	Current
70518-0235	ONDANSETRON	ONDANSETRON	REMEDYREPACK INC.	ANDA	Current
70518-0235	ONDANSETRON	ONDANSETRON	REMEDYREPACK INC.	ANDA	Current
70934-448	ONDANSETRON	ONDANSETRON	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0831	ondansetron	ondansetron	Bryant Ranch Prepack	ANDA	Current