Application 076183

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 24MG BASE	No	No
002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 8MG BASE	No	No
003	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 4MG BASE	No	No
004	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 16MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076183-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26
A076183-002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26
A076183-003	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26
A076183-004	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076183-002	AB
A076183-003	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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076183-001	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL		2006-12-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076183-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2006-12-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076183-003	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2006-12-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076183-004	ONDANSETRON HYDROCHLORIDE	EQ 16MG BASE	TABLET / ORAL		2006-12-26	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 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	A076183-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076183-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076183-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076183-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076183-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076183-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076183-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076183-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076183-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076183-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076183-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076183-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076183-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076183-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076183-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076183-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076183-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076183-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076183-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076183-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076183-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076183-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076183-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076183-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076183-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076183-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076183-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076183-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076183-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076183-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076183-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076183-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076183-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076183-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076183-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076183-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076183-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076183-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076183-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076183-003	AB	1	`bb7c543d1eb4…`

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 HYDROCHLORIDE	Cardinal Health 107, LLC	cb02f2d7-31a9-4f12-880e-7ce7d85440d4	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076183 application number: ANDA076183 ndc (product): 55154-7879
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	4dcd1e4c-6a9c-7ac6-e063-6394a90a39bf	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076183 application number: ANDA076183
ondansetron	ONDANSETRON HYDROCHLORIDE	Major Pharmaceuticals	a29b5c18-9884-4c88-8827-65d9ad5f69f6	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076183 application number: ANDA076183 ndc (product): 0904-6551 ndc (product): 0904-6552
ONDANSETRON	ONDANSETRON HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	162f2088-9fb1-47e7-b88c-45104be7e7bb	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076183 application number: ANDA076183 ndc (product): 55111-156 ndc (product): 55111-154 ndc (product): 55111-153
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	00327696-c496-4c83-a63e-9e29fd6246d4	2024-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076183 application number: ANDA076183 ndc (product): 0615-8185
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	cdb2c4b4-a20a-3f8f-e053-2a95a90aaf72	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076183 application number: ANDA076183 ndc (product): 51662-1539
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	476e704c-95ae-4591-94f7-ee4ab827ff13	2021-05-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076183 application number: ANDA076183 ndc (product): 55111-155

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8185	ondansetron hydrochloride	ondansetron hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8185	ondansetron hydrochloride	ondansetron hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8185	ondansetron hydrochloride	ondansetron hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6551	ondansetron hydrochloride	ondansetron hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6551	ondansetron hydrochloride	ondansetron hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6551	ondansetron hydrochloride	ondansetron hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6551	ondansetron hydrochloride	ondansetron hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6552	ondansetron hydrochloride	ondansetron hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6552	ondansetron hydrochloride	ondansetron hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6552	ondansetron hydrochloride	ondansetron hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6552	ondansetron hydrochloride	ondansetron hydrochloride	Major Pharmaceuticals	ANDA	Current
51662-1539	ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
55111-153	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-153	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-153	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-153	ondansetron hydrochloride	ondansetron hydrochloride	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-154	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-154	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-154	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-154	ondansetron hydrochloride	ondansetron hydrochloride	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-155	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-155	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-156	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-156	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-156	ondansetron hydrochloride	ondansetron hydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-156	ondansetron hydrochloride	ondansetron hydrochloride	Dr.Reddy's Laboratories Limited	ANDA	Current
55154-7879	ondansetron hydrochloride	ondansetron hydrochloride	Cardinal Health	ANDA	Current
70518-1042	ondansetron hydrochloride	ondansetron hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1042	ondansetron hydrochloride	ondansetron hydrochloride	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8874	ORIG	2007-01-08