Home NDC 58602-839-13 Ibuprofen and Pseudoephedrine Hydrochloride
Product NDC 58602-839
Requested package NDC 58602-839-13
11-digit product format 586020839
Labeler code 58602
Product ID 58602-839_8c55a203-6e1b-4f5b-9788-cde24942b6df
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen and Pseudoephedrine Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Aurohealth LLC
Application ANDA213565
Marketing category ANDA
Marketing start 2023-03-10
Substance IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 200; 30 mg/1; mg/1
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10
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 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213565-001 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET / ORAL 2023-03-10 a50c72e98297…
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 Ibuprofen and Pseudoephedrine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 mg/1 PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup 6V9V2RYJ8N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1299021 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 58602-839-13 Ibuprofen and Pseudoephedrine Hydrochloride 8 in 1 BLISTER PACK TABLET, COATED 8 3 58602-839-13 Ibuprofen and Pseudoephedrine Hydrochloride 4 in 1 CARTON TABLET, COATED 4 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58602-839 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED [AUROHEALTH LLC] 3 Current NDC, 2 package rows 20241025_c01116d3-32f8-41f0-8e31-c4142265ef56.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 Sample Exclude flag Status 58602-839-13 58602083913 4 BLISTER PACK in 1 CARTON (58602-839-13) / 8 TABLET, COATED in 1 BLISTER PACK 4 blister pack 2023-03-10 No No Current