Diclofenac Sodium

Product NDC
71335-0648
11-digit product format
713350648
Labeler code
71335
Product ID
71335-0648_cfa0cb80-a307-440c-99c4-88576c0c8bdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075492
Marketing category
ANDA
Marketing start
2000-02-28
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
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075492-001DICLOFENAC SODIUMDICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075492-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-113f01610625f2…
2019-09-15 20:21 UTC2019-09A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075492-001DICLOFENAC SODIUM100MGTABLET, EXTENDED RELEASE / ORALAB2000-02-11e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075492-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075492-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075492-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075492-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075492-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075492-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075492-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075492-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075492-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075492-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075492-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075492-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075492-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075492-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075492-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075492-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075492-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075492-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075492-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075492-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075492-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075492-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075492-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075492-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075492-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075492-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075492-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075492-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075492-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075492-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075492-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075492-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075492-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075492-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075492-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075492-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075492-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075492-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075492-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075492-001AB1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QTG126297QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855657Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
49013aad-475c-4efb-84c6-15a5d4664fbfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0648-1Diclofenac Sodium60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE606
71335-0648-2Diclofenac Sodium30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE306
71335-0648-3Diclofenac Sodium15 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE156
71335-0648-4Diclofenac Sodium14 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE146
71335-0648-5Diclofenac Sodium10 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE106
71335-0648-6Diclofenac Sodium21 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE216
71335-0648-7Diclofenac Sodium90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE906
71335-0648-8Diclofenac Sodium120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1206
71335-0648-9Diclofenac Sodium7 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE76

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0648-1EA - Each71335-06486a114c70-83f6-45e1-bf89-209b82b8f92d12018-09-05
71335-0648-2EA - Each71335-0648ad053f86-384e-4c2c-b653-4a68fdd921df12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0648DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 9 package rows20250221_49013aad-475c-4efb-84c6-15a5d4664fbf.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMOceanside Pharmaceuticalsc48113e0-9f1e-4086-b18f-3204c0d2a6892025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075492
application number: ANDA075492
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPd70fcd8e-a72b-41ef-ac26-e0f2f279f0622025-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075492
application number: ANDA075492
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack49013aad-475c-4efb-84c6-15a5d4664fbf2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075492
application number: ANDA075492
ndc (product): 71335-0648
Diclofenac Sodium ERDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCecaa39b8-067c-80d7-e053-2a95a90a73542024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075492
application number: ANDA075492
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.abacf60f-0410-e6da-e053-2995a90a413c2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075492
application number: ANDA075492
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutionsd9698809-4887-4514-aa28-0066355ef9082023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075492
application number: ANDA075492

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSN49013aad-475c-4efb-84c6-15a5d4664fbf6
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCD49013aad-475c-4efb-84c6-15a5d4664fbf6
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSY49013aad-475c-4efb-84c6-15a5d4664fbf6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0648-17133506480160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-1) 2018-05-220000-00-00NoNoCurrent
71335-0648-27133506480230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-2) 2018-04-130000-00-00NoNoCurrent
71335-0648-37133506480315 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-3) 2025-01-290000-00-00NoNoCurrent
71335-0648-47133506480414 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-4) 2018-07-230000-00-00NoNoCurrent
71335-0648-57133506480510 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-5) 2022-10-130000-00-00NoNoCurrent
71335-0648-67133506480621 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-6) 2018-07-030000-00-00NoNoCurrent
71335-0648-77133506480790 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-7) 2019-04-160000-00-00NoNoCurrent
71335-0648-871335064808120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-8) 2025-01-290000-00-00NoNoCurrent
71335-0648-9713350648097 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-9) 2025-01-29NoNoCurrent