Home NDC 85509-1315 IBUPROFEN AND FAMOTIDINE
Product NDC 85509-1315
11-digit product format 855091315
Labeler code 85509
Product ID 85509-1315_3ff33409-9785-67bc-e063-6394a90ae2f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen and famotidine
Dosage form TABLET
Route ORAL
Labeler PHOENIX RX LLC
Application ANDA216814
Marketing category ANDA
Marketing start 2023-03-15
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 A216814-001 IBUPROFEN AND FAMOTIDINE FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET / ORAL AB 2023-03-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216814-001 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 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216814-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2023-03-15 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 85509-1315-3 IBUPROFEN AND FAMOTIDINE 30 in 1 BOTTLE TABLET 30 1 85509-1315-6 IBUPROFEN AND FAMOTIDINE 60 in 1 BOTTLE TABLET 60 1 85509-1315-9 IBUPROFEN AND FAMOTIDINE 90 in 1 BOTTLE TABLET 90 1
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join IBUPROFEN AND FAMOTIDINE IBUPROFEN AND FAMOTIDINE PHOENIX RX LLC 3ff33400-30e8-87fa-e063-6394a90a7f5c 2025-10-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216814 application number: ANDA216814 ndc (product): 85509-1315 IBUPROFEN AND FAMOTIDINE IBUPROFEN AND FAMOTIDINE Camber Pharmaceuticals, Inc. 7dc158a2-fdfa-4a5f-8c28-0ce5650991db 2024-07-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216814 application number: ANDA216814 IBUPROFEN AND FAMOTIDINE IBUPROFEN AND FAMOTIDINE Advanced Rx Pharmacy of Tennessee, LLC 16c8b0db-37d0-99d9-e063-6394a90ac31b 2024-04-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216814 application number: ANDA216814 IBUPROFEN AND FAMOTIDINE IBUPROFEN AND FAMOTIDINE Ascent Pharmaceuticals, Inc. 03733e49-7db4-4d98-b363-d0d23686ec72 2023-03-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216814 application number: ANDA216814
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85509-1315-3 85509131503 30 TABLET in 1 BOTTLE (85509-1315-3) 30 tablet 2025-09-29 No No Current 85509-1315-6 85509131506 60 TABLET in 1 BOTTLE (85509-1315-6) 60 tablet 2025-09-29 No No Current 85509-1315-9 85509131509 90 TABLET in 1 BOTTLE (85509-1315-9) 90 tablet 2025-09-29 No No Current