Home NDC 68382-013 Naproxen
Product NDC 68382-013
11-digit product format 683820013
Labeler code 68382
Product ID 68382-013_29a5000d-5ff1-4482-ad9d-3d36570b1e67
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA078620
Marketing category ANDA
Marketing start 2008-09-19
Marketing end 0000-00-00
Substance NAPROXEN
Active strength 375 mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68382-013-05 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68382-013-10 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68382-013-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68382-013-05 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68382-013-10 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68382-013-01 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078620-001 NAPROXEN NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 A078620-002 NAPROXEN NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 A078620-003 NAPROXEN NAPROXEN 500MG TABLET / ORAL AB 2007-06-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 129 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 2026-09-14 22:38:34 2026-08 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078620-002 NAPROXEN 375MG TABLET / ORAL AB 2007-06-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078620-003 NAPROXEN 500MG TABLET / ORAL AB 2007-06-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078620-001 NAPROXEN 250MG TABLET / ORAL AB 2007-06-07 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68382-013-01 68382001301 100 TABLET in 1 BOTTLE (68382-013-01) 100 tablet 2008-09-19 0000-00-00 No No Current 68382-013-05 68382001305 500 TABLET in 1 BOTTLE (68382-013-05) 500 tablet 2008-09-19 0000-00-00 No No Current 68382-013-10 68382001310 1000 TABLET in 1 BOTTLE (68382-013-10) 1000 tablet 2008-09-19 0000-00-00 No No Current