Diclofenac Sodium

Product NDC: 16571-202
11-digit product format: 165710202
Labeler code: 16571
Product ID: 16571-202_504b1904-033c-4fd8-92c9-41e31154f808
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA090066
Marketing category: ANDA
Marketing start: 2010-12-31
Substance: DICLOFENAC SODIUM
Active strength: 50 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], 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 1.

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
A090066-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01
A090066-002	DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090066-001	AB
A090066-002	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 · 82 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	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB		2010-12-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB		2010-12-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090066-001	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090066-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2010-12-01	`782e0a99824c…`

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
2026-02-19 14:30 UTC	2026-02	A090066-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090066-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090066-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090066-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090066-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090066-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090066-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090066-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090066-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090066-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090066-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090066-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090066-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090066-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090066-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090066-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090066-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090066-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090066-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090066-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090066-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090066-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090066-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090066-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090066-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090066-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090066-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090066-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090066-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090066-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090066-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090066-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090066-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090066-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090066-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090066-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090066-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090066-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090066-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090066-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC SODIUM	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
QTG126297Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855664	Internal RxNorm lookup
855906	Internal RxNorm lookup
855926	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
3330ea92-fc9d-4541-b378-be399b0995d3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16571-202-06	Diclofenac Sodium	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	20
16571-202-10	Diclofenac Sodium	100 in 1 BOTTLE	TABLET, DELAYED RELEASE	100	20
16571-202-11	Diclofenac Sodium	1000 in 1 BOTTLE	TABLET, DELAYED RELEASE	1000	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-202-06	EA - Each	16571-202	b9acc384-42e3-42b7-bfcf-79dabfcbd936	1	2012-07-24
16571-202-10	EA - Each	16571-202	e4788a5f-1b95-4dab-9429-679697971d19	1	2012-07-24
16571-202-11	EA - Each	16571-202	2a91f78e-a661-4a85-8d05-e90a98e6d5b8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diclofenac Sodium	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3965
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3965
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3965
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3965
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3965
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3965
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3965
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3965
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3965
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3965
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3965
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3965
povidone	INACTIVE INGREDIENT	FZ989GH94E	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3965
talc	INACTIVE INGREDIENT	7SEV7J4R1U	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3965
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3965
water	INACTIVE INGREDIENT	059QF0KO0R	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3965
Diclofenac Sodium	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]	7
Diclofenac	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]	7
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]	7
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]	7
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-202	DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMA HOLDINGS, INC.]	18	Current NDC, Legacy NDC, 3 package rows	20250418_3330ea92-fc9d-4541-b378-be399b0995d3.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	American Health Packaging	63c00b50-06d3-4659-81cf-be4516429e81	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090066 application number: ANDA090066
Diclofenac Sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090066 application number: ANDA090066
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	4ee64a93-9965-47c8-be2c-14232df44b2b	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090066 application number: ANDA090066
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	1e669fc2-69bf-4439-a336-a103e5b9cafe	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090066 application number: ANDA090066
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	8825dc2c-3497-455f-b5e1-2aa667291957	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090066 application number: ANDA090066
Diclofenac Sodium	DICLOFENAC SODIUM	BluePoint Laboratories	feb1541a-de83-47dd-be03-c43376527318	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090066 application number: ANDA090066
Diclofenac Sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	4e97c685-628a-4b83-ba9e-2d3caf65542b	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090066 application number: ANDA090066
Diclofenac Sodium	DICLOFENAC SODIUM	Rising Pharma Holdings, Inc.	3330ea92-fc9d-4541-b378-be399b0995d3	2025-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090066 application number: ANDA090066 ndc (product): 16571-202
Diclofenac Sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	af480e78-ff65-4709-af26-c430aefb77d6	2025-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090066 application number: ANDA090066
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	b3dbd981-453c-645f-e053-2a95a90aec3c	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090066 application number: ANDA090066
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	9eeb2aef-3eb1-4583-8180-d480deb3651c	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090066 application number: ANDA090066

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QTG126297Q	DICLOFENAC SODIUM	15307-79-6	DICLOFENAC SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	PSN	bfa8cb40-3528-4d41-ae77-444e521e30c0	3981
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	PSN	bfa8cb40-3528-4d41-ae77-444e521e30c0	3981
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	SCD	bfa8cb40-3528-4d41-ae77-444e521e30c0	3981
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	SCD	bfa8cb40-3528-4d41-ae77-444e521e30c0	3981
855664	diclofenac sodium 25 MG Delayed Release Oral Tablet	PSN	3330ea92-fc9d-4541-b378-be399b0995d3	20
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	PSN	3330ea92-fc9d-4541-b378-be399b0995d3	20
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	PSN	3330ea92-fc9d-4541-b378-be399b0995d3	20
855664	diclofenac sodium 25 MG Delayed Release Oral Tablet	SCD	3330ea92-fc9d-4541-b378-be399b0995d3	20
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	SCD	3330ea92-fc9d-4541-b378-be399b0995d3	20
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	SCD	3330ea92-fc9d-4541-b378-be399b0995d3	20
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	PSN	1e669fc2-69bf-4439-a336-a103e5b9cafe	17
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	PSN	1e669fc2-69bf-4439-a336-a103e5b9cafe	17
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	SCD	1e669fc2-69bf-4439-a336-a103e5b9cafe	17
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	SCD	1e669fc2-69bf-4439-a336-a103e5b9cafe	17
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	PSN	8825dc2c-3497-455f-b5e1-2aa667291957	7
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	PSN	b3dbd981-453c-645f-e053-2a95a90aec3c	7
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	SCD	b3dbd981-453c-645f-e053-2a95a90aec3c	7
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	SCD	8825dc2c-3497-455f-b5e1-2aa667291957	7
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	PSN	9eeb2aef-3eb1-4583-8180-d480deb3651c	5
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	PSN	63c00b50-06d3-4659-81cf-be4516429e81	5
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	SCD	9eeb2aef-3eb1-4583-8180-d480deb3651c	5
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	SCD	63c00b50-06d3-4659-81cf-be4516429e81	5
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	PSN	4e4112f6-0c9a-26d7-e054-00144ff8d46c	4
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	SCD	4e4112f6-0c9a-26d7-e054-00144ff8d46c	4
855664	diclofenac sodium 25 MG Delayed Release Oral Tablet	PSN	2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8	2
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	PSN	4ee64a93-9965-47c8-be2c-14232df44b2b	2
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	PSN	27f60ba8-a335-33b2-e054-00144ff8d46c	2
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	PSN	af480e78-ff65-4709-af26-c430aefb77d6	2
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	PSN	2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8	2
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	PSN	2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8	2
855664	diclofenac sodium 25 MG Delayed Release Oral Tablet	SCD	2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8	2
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	SCD	4ee64a93-9965-47c8-be2c-14232df44b2b	2
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	SCD	27f60ba8-a335-33b2-e054-00144ff8d46c	2
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	SCD	af480e78-ff65-4709-af26-c430aefb77d6	2
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	SCD	2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8	2
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	SCD	2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8	2
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	PSN	1ea0a3ac-88ab-48c1-e054-00144ff8d46c	1
855906	diclofenac sodium 50 MG Delayed Release Oral Tablet	SCD	1ea0a3ac-88ab-48c1-e054-00144ff8d46c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16571-202-06	16571020206	60 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-202-06)	2010-12-31	0000-00-00	No	No	Current
16571-202-10	16571020210	100 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-202-10)	2010-12-31	0000-00-00	No	No	Current
16571-202-11	16571020211	1000 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-202-11)	2010-12-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium Delayed-Release Tablets, USP Rx Only 8233301/0725F	American Health Packaging	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL	6
Diclofenac Sodium Delayed-release Tablets, USP 25 mg, 50 mg and 75 mg	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-03-25	HUMAN PRESCRIPTION DRUG LABEL	2
Diclofenac Sodium Delayed-release Tablets, USP 25 mg, 50 mg and 75 mg	Preferred Pharmaceuticals Inc.	2026-01-21	HUMAN PRESCRIPTION DRUG LABEL	2
Diclofenac Sodium Delayed-release Tablets, USP 25 mg, 50 mg and 75 mg	A-S Medication Solutions	2026-01-08	Human Prescription Drug Label	17
Diclofenac Sodium Delayed-release Tablets, USP 25 mg, 50 mg and 75 mg	A-S Medication Solutions	2026-01-08	Human Prescription Drug Label	7
Diclofenac Sodium Delayed-release Tablets, USP 25 mg, 50 mg and 75 mg	Rising Pharma Holdings, Inc. \| Unique Pharmaceutical Laboratories	2025-08-05	Human Prescription Drug Label	20
Diclofenac Sodium Delayed-release Tablets, USP 25 mg, 50 mg and 75 mg	Bryant Ranch Prepack	2025-02-10	HUMAN PRESCRIPTION DRUG LABEL	2
Diclofenac Sodium DR 50mg Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	7
Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg	Quality Care Products LLC	2024-12-11	HUMAN PRESCRIPTION DRUG LABEL	3981
Diclofenac Sodium Delayed-Release Tablets, USP 25 mg, 50 mg and 75 mg	Proficient Rx LP	2022-05-02	HUMAN PRESCRIPTION DRUG LABEL	5
Diclofenac Sodium - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	4
DICLOFENAC SODIUM	DirectRX	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg	Blenheim Pharmacal, Inc.	2015-08-31	HUMAN PRESCRIPTION DRUG LABEL	1