Home NDC 80425-0483 Ibuprofen and famotidine
Product NDC 80425-0483
11-digit product format 804250483
Labeler code 80425
Product ID 80425-0483_2cf74136-002a-d2a4-e063-6294a90ae545
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen and famotidine
Dosage form TABLET
Route ORAL
Labeler Advanced Rx of Tennessee, LLC
Application ANDA203658
Marketing category ANDA
Marketing start 2024-03-22
Substance FAMOTIDINE; IBUPROFEN
Active strength 26.6; 800 mg/1; mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], 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 A203658-001 IBUPROFEN AND FAMOTIDINE FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET / ORAL AB 2024-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203658-001 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 A203658-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2024-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203658-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2024-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203658-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2024-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203658-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2024-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203658-001 FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET / ORAL AB 2024-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203658-001 FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET / ORAL AB 2024-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203658-001 FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET / ORAL AB 2024-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203658-001 FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET / ORAL AB 2024-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203658-001 FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET / ORAL AB 2024-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203658-001 FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET / ORAL AB 2024-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203658-001 FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET / ORAL AB 2024-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203658-001 FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET / ORAL AB 2024-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203658-001 FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET / ORAL AB 2024-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203658-001 FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET / ORAL AB 2024-03-22 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A203658-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2024-03-22 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen and famotidine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 26.6 mg/1 FAMOTIDINE 800 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 5QZO15J2Z8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1100066 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 80425-0483-1 Ibuprofen and famotidine 30 in 1 BOTTLE TABLET 30 1 80425-0483-2 Ibuprofen and famotidine 60 in 1 BOTTLE TABLET 60 1 80425-0483-3 Ibuprofen and famotidine 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0483 IBUPROFEN AND FAMOTIDINE TABLET [ADVANCED RX OF TENNESSEE, LLC] 1 Current NDC, 3 package rows 20250201_2cf7412a-7f94-e39f-e063-6294a90a5bc2.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 · 2 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 80425-0483-1 80425048301 30 TABLET in 1 BOTTLE (80425-0483-1) 30 tablet 2024-03-22 No No Current 80425-0483-2 80425048302 60 TABLET in 1 BOTTLE (80425-0483-2) 60 tablet 2024-03-22 No No Current 80425-0483-3 80425048303 90 TABLET in 1 BOTTLE (80425-0483-3) 90 tablet 2024-03-22 No No Current