ONDANSETRON

Product NDC: 55111-156
11-digit product format: 551110156
Labeler code: 55111
Product ID: 55111-156_b5be4b6c-42cd-c9b3-a0df-e15c946ec89b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ONDANSETRON HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Dr. Reddy's Laboratories Limited
Application: ANDA076183
Marketing category: ANDA
Marketing start: 2006-12-26
Substance: ONDANSETRON HYDROCHLORIDE
Active strength: 24 mg/1
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
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 · 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON HYDROCHLORIDE	24 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NMH84OZK2B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198052	Internal RxNorm lookup
312084	Internal RxNorm lookup
312086	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
162f2088-9fb1-47e7-b88c-45104be7e7bb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d9bd4853-037c-6968-f4d4-9bb9a0efd1ea	Product name	2	20250722
32e23bc9-ce14-4555-bb6d-bcb654d7d296	Product name	1	20201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49	Product name	1	20201015
909480fe-0d18-c1c1-a658-0bd9a7131822	Product name	5	20170829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
55111-156-05	2020-05-14	These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-156-11	2020-05-14	These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-156-30	2020-05-14	These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-156-78	2020-05-14	These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-156-05	2020-01-31	These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-156-11	2020-01-31	These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-156-30	2020-01-31	These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-156-78	2020-01-31	These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55111-156-05	ONDANSETRON	500 in 1 BOTTLE	TABLET, FILM COATED	500	17
55111-156-11	ONDANSETRON	1 in 1 DOSE PACK	TABLET, FILM COATED	1	17
55111-156-11	ONDANSETRON	1 in 1 BOX	TABLET, FILM COATED	1	17
55111-156-30	ONDANSETRON	30 in 1 BOTTLE	TABLET, FILM COATED	30	17
55111-156-78	ONDANSETRON	10 in 1 BOX	TABLET, FILM COATED	10	17
55111-156-79	ONDANSETRON	10 in 1 DOSE PACK	TABLET, FILM COATED	10	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-156-11	EA - Each	55111-156	76077a43-600d-4d2c-b1f6-06749e6cd09c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	8
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	8
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	8
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	8
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	8
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	8
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	8
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-156	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]	16	Current NDC, Legacy NDC, 6 package rows	20250315_162f2088-9fb1-47e7-b88c-45104be7e7bb.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 · 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
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
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
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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NMH84OZK2B	ONDANSETRON HYDROCHLORIDE	103639-04-9	ONDANSETRON HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312084	ondansetron 24 MG Oral Tablet	PSN	162f2088-9fb1-47e7-b88c-45104be7e7bb	17
198052	ondansetron HCl 4 MG Oral Tablet	PSN	162f2088-9fb1-47e7-b88c-45104be7e7bb	17
312086	ondansetron HCl 8 MG Oral Tablet	PSN	162f2088-9fb1-47e7-b88c-45104be7e7bb	17
312084	ondansetron 24 MG Oral Tablet	SCD	162f2088-9fb1-47e7-b88c-45104be7e7bb	17
198052	ondansetron 4 MG Oral Tablet	SCD	162f2088-9fb1-47e7-b88c-45104be7e7bb	17
312086	ondansetron 8 MG Oral Tablet	SCD	162f2088-9fb1-47e7-b88c-45104be7e7bb	17
312084	ondansetron 24 MG (ondansetron hydrochloride dihydrate 30 MG) Oral Tablet	SY	162f2088-9fb1-47e7-b88c-45104be7e7bb	17
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	162f2088-9fb1-47e7-b88c-45104be7e7bb	17
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	162f2088-9fb1-47e7-b88c-45104be7e7bb	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55111-156-05	55111015605	500 TABLET, FILM COATED in 1 BOTTLE (55111-156-05)		2006-12-26	0000-00-00	No	No	Current
55111-156-11	55111015611	1 DOSE PACK in 1 BOX (55111-156-11) / 1 TABLET, FILM COATED in 1 DOSE PACK	1 dose pack	2006-12-26	0000-00-00	No	No	Current
55111-156-30	55111015630	30 TABLET, FILM COATED in 1 BOTTLE (55111-156-30)		2006-12-26	0000-00-00	No	No	Current
55111-156-78	55111015678	10 DOSE PACK in 1 BOX (55111-156-78) / 10 TABLET, FILM COATED in 1 DOSE PACK (55111-156-79)	10 dose pack	2006-12-26	0000-00-00	No	No	Current
55111-156-79	55111015679	10 in 1 DOSE PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ONDANSETRON	Dr. Reddy's Laboratories Limited \| Dr. Reddy's Laboratories Limited-FTO III	2025-06-30	HUMAN PRESCRIPTION DRUG LABEL	17