Home NDC 31722-046 Diclofenac potassium
Product NDC 31722-046
11-digit product format 317220046
Labeler code 31722
Product ID 31722-046_2d0e1b57-79e2-61da-e063-6394a90a214e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac potassium
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA215375
Marketing category ANDA
Marketing start 2022-03-04
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 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 A215375-001 DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215375-001 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 2026-02-19 14:30 UTC 2026-02 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 4b0b4de00fa7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215375-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2022-03-04 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 31722-046-31 Diclofenac potassium 1 in 1 PACKET POWDER, FOR SOLUTION 1 3 31722-046-32 Diclofenac potassium 9 in 1 CARTON POWDER, FOR SOLUTION 9 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-046 DICLOFENAC POTASSIUM POWDER, FOR SOLUTION [CAMBER PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20250202_9261a9d6-f772-41a2-ac99-8608c04c355b.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 Marketing start Marketing end Sample Exclude flag Status 31722-046-31 31722004631 1 POWDER, FOR SOLUTION in 1 PACKET (31722-046-31) 2022-03-04 0000-00-00 No No Current 31722-046-32 31722004632 9 POWDER, FOR SOLUTION in 1 CARTON (31722-046-32) 2022-03-04 0000-00-00 No No Current