RELAFEN DS

Product NDC: 15370-170
11-digit product format: 153700170
Labeler code: 15370
Product ID: 15370-170_48aa3640-1dd2-4693-9b0d-a99595b97a0e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NABUMETONE
Dosage form: TABLET
Route: ORAL
Labeler: Carwin Pharmaceutical Associates, LLC
Application: ANDA203166
Marketing category: ANDA
Marketing start: 2019-09-20
Substance: NABUMETONE
Active strength: 1000 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [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 42.

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
A203166-001	NABUMETONE	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30
A203166-002	NABUMETONE	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30
A203166-003	NABUMETONE	NABUMETONE	1GM	TABLET / ORAL		RS	2019-08-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203166-001	AB
A203166-002	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 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
2026-08-18 06:07:40	2026-07	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203166-003	NABUMETONE	1GM	TABLET / ORAL		RS	2019-08-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203166-003	NABUMETONE	1GM	TABLET / ORAL		RS	2019-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203166-002	NABUMETONE	750MG	TABLET / ORAL	AB		2019-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203166-003	NABUMETONE	1GM	TABLET / ORAL			2019-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203166-001	NABUMETONE	500MG	TABLET / ORAL	AB		2019-08-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203166-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203166-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203166-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203166-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203166-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203166-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203166-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203166-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203166-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203166-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203166-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203166-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203166-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203166-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203166-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203166-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203166-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203166-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203166-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203166-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203166-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203166-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203166-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203166-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203166-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203166-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203166-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203166-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203166-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203166-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203166-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203166-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203166-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203166-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203166-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203166-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203166-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203166-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203166-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203166-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NABUMETONE	1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LW0TIW155Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
427726	Internal RxNorm lookup
2200291	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
a9a0af85-6c43-4a2d-ba75-0be4ca64c931	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9d4d18c4-d38e-37e1-df1c-ee38762bf8a5	Product name	4	20251024

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
15370-170-10	RELAFEN DS	100 in 1 BOTTLE, PLASTIC	TABLET	100	5
15370-170-30	RELAFEN DS	30 in 1 BOTTLE, PLASTIC	TABLET	30	5
15370-170-60	RELAFEN DS	60 in 1 BOTTLE, PLASTIC	TABLET	60	5
15370-170-99	RELAFEN DS	1 in 1 CARTON	TABLET	1	5
15370-170-99	RELAFEN DS	2 in 1 BLISTER PACK	TABLET	2	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
15370-170-30	EA - Each	15370-170	43903e88-4ddf-4457-8352-20d1bb9cd0d0	1	2019-10-07
15370-170-60	EA - Each	15370-170	e43711fe-793a-4163-bb20-d37e65fdf6a8	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15370-170	RELAFEN DS (NABUMETONE) TABLET [CARWIN PHARMACEUTICAL ASSOCIATES, LLC]	5	Current NDC, Legacy NDC, 5 package rows	20240110_a9a0af85-6c43-4a2d-ba75-0be4ca64c931.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nabumetone 500 mg	NABUMETONE	LGM PHARMA SOLUTIONS, LLC	ef7c3da8-797f-4ea9-8999-53509785a0f7	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203166 application number: ANDA203166
RELAFEN DS	NABUMETONE	Carwin Pharmaceutical Associates, LLC	a9a0af85-6c43-4a2d-ba75-0be4ca64c931	2024-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203166 application number: ANDA203166 ndc (product): 15370-170

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LW0TIW155Z	NABUMETONE	42924-53-8	NABUMETONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
427726	nabumetone 1000 MG Oral Tablet	PSN	a9a0af85-6c43-4a2d-ba75-0be4ca64c931	5
2200291	Relafen DS 1000 MG Oral Tablet	PSN	a9a0af85-6c43-4a2d-ba75-0be4ca64c931	5
2200291	nabumetone 1000 MG Oral Tablet [Relafen]	SBD	a9a0af85-6c43-4a2d-ba75-0be4ca64c931	5
427726	nabumetone 1000 MG Oral Tablet	SCD	a9a0af85-6c43-4a2d-ba75-0be4ca64c931	5
2200291	Relafen 1000 MG Oral Tablet	SY	a9a0af85-6c43-4a2d-ba75-0be4ca64c931	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
15370-170-10	15370017010	100 TABLET in 1 BOTTLE, PLASTIC (15370-170-10)	100 tablet	2022-05-12	0000-00-00	No	No	Current
15370-170-30	15370017030	30 TABLET in 1 BOTTLE, PLASTIC (15370-170-30)	30 tablet	2019-09-20	0000-00-00	No	No	Current
15370-170-60	15370017060	60 TABLET in 1 BOTTLE, PLASTIC (15370-170-60)	60 tablet	2020-02-28	0000-00-00	No	No	Current
15370-170-99	15370017099	1 BLISTER PACK in 1 CARTON (15370-170-99) / 2 TABLET in 1 BLISTER PACK	1 blister pack	2020-02-28	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nabumetone Tablets, USP	Carwin Pharmaceutical Associates, LLC	2024-01-08	HUMAN PRESCRIPTION DRUG LABEL	5