Home NDC 67877-772 Diclofenac Potassium
Product NDC 67877-772
11-digit product format 678770772
Labeler code 67877
Product ID 67877-772_2b2c8805-3cf1-48f8-9612-8a72a30a7f20
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Potassium
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA216635
Marketing category ANDA
Marketing start 2022-10-24
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216635-001 DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216635-001 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.
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 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216635-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-07-20 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 859063 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 67877-772-49 Diclofenac Potassium 1 in 1 PACKET POWDER, FOR SOLUTION 1 4 67877-772-58 Diclofenac Potassium 9 in 1 CARTON POWDER, FOR SOLUTION 9 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-772 DICLOFENAC POTASSIUM POWDER, FOR SOLUTION [ASCEND LABORATORIES, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20221024_f675a627-c944-4ec6-8c08-b5fdb78dc269.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67877-772-49 67877077249 1 in 1 PACKET Historical 67877-772-58 67877077258 9 PACKET in 1 CARTON (67877-772-58) / 1 POWDER, FOR SOLUTION in 1 PACKET (67877-772-49) 9 packet 2022-10-24 0000-00-00 No No Current