Diclofenac Sodium

Product NDC: 61314-014
11-digit product format: 613140014
Labeler code: 61314
Product ID: 61314-014_202278f8-31f7-4c24-ae96-8065430d6a7d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Sandoz Inc
Application: ANDA078031
Marketing category: ANDA
Marketing start: 2008-02-14
Substance: DICLOFENAC SODIUM
Active strength: 1 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078031-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2008-02-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078031-001	AT

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 · 41 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	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078031-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-02-06	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A078031-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078031-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078031-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078031-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078031-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078031-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078031-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078031-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078031-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078031-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078031-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078031-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078031-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078031-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078031-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078031-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078031-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078031-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078031-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078031-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078031-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078031-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078031-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078031-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078031-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078031-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078031-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078031-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078031-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078031-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078031-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078031-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078031-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078031-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078031-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078031-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078031-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078031-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078031-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078031-001	AT	1	`cb3db0bc1861…`

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	1 mg/mL

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
854801	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
52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
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
61314-014-05	Diclofenac Sodium	5 mL in 1 BOTTLE	SOLUTION	5	7
61314-014-05	Diclofenac Sodium	1 in 1 CARTON	SOLUTION	1	7
61314-014-25	Diclofenac Sodium	1 in 1 CARTON	SOLUTION	1	7
61314-014-25	Diclofenac Sodium	2.5 mL in 1 BOTTLE	SOLUTION	2.5	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61314-014-05	ML - Milliliter	61314-014	a52f7e4c-3267-4c4c-8e38-2cb6d9442573	1	2012-07-24
61314-014-25	ML - Milliliter	61314-014	ab7d2340-c8c7-4e03-baa1-a023f9f720a1	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 SOLUTION [SANDOZ INC]	2
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM SOLUTION [SANDOZ INC]	2
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	DICLOFENAC SODIUM SOLUTION [SANDOZ INC]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DICLOFENAC SODIUM SOLUTION [SANDOZ INC]	2
POLYOXYL 35 CASTOR OIL	INACTIVE INGREDIENT	6D4M1DAL6O	DICLOFENAC SODIUM SOLUTION [SANDOZ INC]	2
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	DICLOFENAC SODIUM SOLUTION [SANDOZ INC]	2
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	DICLOFENAC SODIUM SOLUTION [SANDOZ INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DICLOFENAC SODIUM SOLUTION [SANDOZ INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61314-014	DICLOFENAC SODIUM SOLUTION [SANDOZ INC]	7	Current NDC, Legacy NDC, 4 package rows	20241206_52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b.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
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	3a520306-fe3e-4830-963f-04b080db3abc	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078031 application number: ANDA078031
Diclofenac Sodium	DICLOFENAC SODIUM	Sandoz Inc	52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b	2021-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078031 application number: ANDA078031 ndc (product): 61314-014

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
854801	diclofenac sodium 0.1 % Ophthalmic Solution	PSN	52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b	7
854801	diclofenac sodium 1 MG/ML Ophthalmic Solution	SCD	52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b	7
854801	diclofenac sodium 0.1 % Ophthalmic Solution	SY	52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b	7
854801	diclofenac sodium 0.1 % Ophthalmic Solution	PSN	3a520306-fe3e-4830-963f-04b080db3abc	6
854801	diclofenac sodium 1 MG/ML Ophthalmic Solution	SCD	3a520306-fe3e-4830-963f-04b080db3abc	6
854801	diclofenac sodium 0.1 % Ophthalmic Solution	SY	3a520306-fe3e-4830-963f-04b080db3abc	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61314-014-05	61314001405	1 BOTTLE in 1 CARTON (61314-014-05) / 5 mL in 1 BOTTLE	1 bottle	2018-02-14	0000-00-00	No	No	Current
61314-014-25	61314001425	1 BOTTLE in 1 CARTON (61314-014-25) / 2.5 mL in 1 BOTTLE	1 bottle	2018-02-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium	A-S Medication Solutions	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	6
Diclofenac Sodium	NuCare Pharmaceuticals,Inc.	2022-01-28	HUMAN PRESCRIPTION DRUG LABEL	2
Diclofenac Sodium	Sandoz Inc	2021-09-29	HUMAN PRESCRIPTION DRUG LABEL	7