Home NDC 15370-185 Diclofenac Potassium
Product NDC 15370-185
11-digit product format 153700185
Labeler code 15370
Product ID 15370-185_95ce3601-808d-47ed-9fe0-0f974068c075
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DICLOFENAC POTASSIUM
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Carwin Pharmaceutical Associates, LLC
Application ANDA076561
Marketing category ANDA
Marketing start 2023-11-01
Substance DICLOFENAC POTASSIUM
Active strength 25 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076561-001 CATAFLAM DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2004-03-18 A076561-002 CATAFLAM DICLOFENAC POTASSIUM 25MG TABLET / ORAL AB 2021-07-21
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.
Product history page 1 of 2 · 76 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 2026-08-18 06:07:40 2026-07 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076561-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2004-03-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076561-002 CATAFLAM 25MG TABLET / ORAL AB 2021-07-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076561-001 CATAFLAM 50MG TABLET / ORAL AB 2004-03-18 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Diclofenac Potassium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOFENAC POTASSIUM 25 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 857702 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 15370-185-30 Diclofenac Potassium 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 2 15370-185-60 Diclofenac Potassium 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 15370-185 DICLOFENAC POTASSIUM TABLET, FILM COATED [CARWIN PHARMACEUTICAL ASSOCIATES, LLC] 2 Current NDC, 2 package rows 20250410_bce95bb3-3097-4e7d-8d29-0870bb729212.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 Golden State Medical Supply, Inc. c2c79af6-f35e-5cdf-e053-2a95a90a4d63 2025-06-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076561 application number: ANDA076561 Diclofenac Potassium DICLOFENAC POTASSIUM Amici Pharma Inc. f2908870-a517-491f-8771-4100d11b4b64 2025-06-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076561 application number: ANDA076561 LOFENA DICLOFENAC POTASSIUM Carwin Pharmaceutical Associates, LLC 49bd64cc-5edb-44f2-8e24-1249f6a76663 2024-01-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076561 application number: ANDA076561 Diclofenac Potassium DICLOFENAC POTASSIUM Carwin Pharmaceutical Associates, LLC bce95bb3-3097-4e7d-8d29-0870bb729212 2023-11-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076561 application number: ANDA076561 ndc (product): 15370-185
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 15370-185-30 15370018530 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15370-185-30) 2023-11-01 No No Current 15370-185-60 15370018560 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15370-185-60) 2025-04-08 No No Current