Home NDC 71335-9720 Diclofenac Potassium
Product NDC 71335-9720
11-digit product format 713359720
Labeler code 71335
Product ID 71335-9720_78a4857d-93b6-4a0e-93fc-75b02be9fa61
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Potassium Tablets
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA215750
Marketing category ANDA
Marketing start 2022-05-12
Substance DICLOFENAC POTASSIUM
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A215750-001 DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 A215750-002 DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 25MG TABLET / ORAL AB 2025-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
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 2026-10-15 13:18:30 2026-09 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A215750-002 DICLOFENAC POTASSIUM 25MG TABLET / ORAL AB 2025-06-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215750-002 DICLOFENAC POTASSIUM 25MG TABLET / ORAL AB 2025-06-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215750-002 DICLOFENAC POTASSIUM 25MG TABLET / ORAL AB 2025-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215750-002 DICLOFENAC POTASSIUM 25MG TABLET / ORAL AB 2025-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215750-002 DICLOFENAC POTASSIUM 25MG TABLET / ORAL AB 2025-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215750-002 DICLOFENAC POTASSIUM 25MG TABLET / ORAL AB 2025-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215750-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2022-05-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215750-002 DICLOFENAC POTASSIUM 25MG TABLET / ORAL AB 2025-06-30 a50c72e98297…
Observed Orange Book normalized TE history# 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 Potassium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOFENAC POTASSIUM 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L4D5UA6CB4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855942 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-9720-1 Diclofenac Potassium 20 in 1 BOTTLE TABLET, FILM COATED 20 104 71335-9720-2 Diclofenac Potassium 90 in 1 BOTTLE TABLET, FILM COATED 90 104 71335-9720-3 Diclofenac Potassium 30 in 1 BOTTLE TABLET, FILM COATED 30 104 71335-9720-4 Diclofenac Potassium 60 in 1 BOTTLE TABLET, FILM COATED 60 104 71335-9720-5 Diclofenac Potassium 45 in 1 BOTTLE TABLET, FILM COATED 45 104 71335-9720-6 Diclofenac Potassium 58 in 1 BOTTLE TABLET, FILM COATED 58 104 71335-9720-7 Diclofenac Potassium 18 in 1 BOTTLE TABLET, FILM COATED 18 104 71335-9720-8 Diclofenac Potassium 120 in 1 BOTTLE TABLET, FILM COATED 120 104 71335-9720-9 Diclofenac Potassium 100 in 1 BOTTLE TABLET, FILM COATED 100 104
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-9720 DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM TABLETS) TABLET, FILM COATED [BRYANT RANCH PREPACK] 103 Current NDC, 9 package rows 20250303_94898228-c595-4fd6-acc2-13dbdbde9c0e.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diclofenac Potassium DICLOFENAC POTASSIUM TABLETS Bryant Ranch Prepack 94898228-c595-4fd6-acc2-13dbdbde9c0e 2026-04-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215750 application number: ANDA215750 ndc (product): 71335-9720 Diclofenac Potassium DICLOFENAC POTASSIUM TABLETS NIVAGEN PHARMACEUTICALS, INC. 1f06a404-07c3-4414-8c5c-357c01d6ccb3 2025-12-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215750 application number: ANDA215750 Diclofenac Potassium DICLOFENAC POTASSIUM TABLETS NuCare Pharmaceuticals,Inc. ffc41543-a353-cade-e053-6294a90a99fb 2025-02-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215750 application number: ANDA215750 Diclofenac Potassium DICLOFENAC POTASSIUM TABLETS A-S Medication Solutions 5d37fc5a-7a2f-432e-b4e9-e00c246ce33c 2023-10-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215750 application number: ANDA215750
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71335-9720-1 71335972001 20 TABLET, FILM COATED in 1 BOTTLE (71335-9720-1) 2026-04-09 No No Current 71335-9720-2 71335972002 90 TABLET, FILM COATED in 1 BOTTLE (71335-9720-2) 2023-10-17 No No Current 71335-9720-3 71335972003 30 TABLET, FILM COATED in 1 BOTTLE (71335-9720-3) 2023-05-11 No No Current 71335-9720-4 71335972004 60 TABLET, FILM COATED in 1 BOTTLE (71335-9720-4) 2023-11-15 No No Current 71335-9720-5 71335972005 45 TABLET, FILM COATED in 1 BOTTLE (71335-9720-5) 2026-04-09 No No Current 71335-9720-6 71335972006 58 TABLET, FILM COATED in 1 BOTTLE (71335-9720-6) 2026-04-09 No No Current 71335-9720-7 71335972007 18 TABLET, FILM COATED in 1 BOTTLE (71335-9720-7) 2026-04-09 No No Current 71335-9720-8 71335972008 120 TABLET, FILM COATED in 1 BOTTLE (71335-9720-8) 2026-04-09 No No Current 71335-9720-9 71335972009 100 TABLET, FILM COATED in 1 BOTTLE (71335-9720-9) 2026-04-09 No No Current