DICLOFENAC SODIUM

Product NDC: 84386-103
Requested package NDC: 84386-103-01
11-digit product format: 843860103
Labeler code: 84386
Product ID: 84386-103_d9b6f1d0-1710-46fb-8ea4-80b3ca60a575
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DICLOFENAC SODIUM
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA076152
Marketing category: ANDA
Marketing start: 2026-07-16
Substance: DICLOFENAC SODIUM
Active strength: 100 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076152-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076152-001	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 2 · 43 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	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2001-12-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2001-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL		2001-12-13	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076152-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076152-001	AB	1	`caaa826d4ba7…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: DICLOFENAC SODIUM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC SODIUM	100 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855657	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
d9b6f1d0-1710-46fb-8ea4-80b3ca60a575	Available on FDA.report

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Aurobindo Pharma Limited	d9b6f1d0-1710-46fb-8ea4-80b3ca60a575	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076152 application number: ANDA076152 ndc (package): 84386-103-01 ndc (product): 84386-103 ndc11 (package): 84386010301

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
84386-103-01	84386010301	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84386-103-01)	2026-07-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DICLOFENAC SODIUM	Aurobindo Pharma Limited \| Aurovitas Pharma Taizhou Co.,LTD	2026-07-17	Human Prescription Drug Label	1