Home NDC 49884-366 Ibuprofen and famotidine
Product NDC 49884-366
11-digit product format 498840366
Labeler code 49884
Product ID 49884-366_42b48d54-e6f0-496b-8452-bf604b66b4bb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen and famotidine
Dosage form TABLET
Route ORAL
Labeler Par Health USA, LLC
Application ANDA203658
Marketing category ANDA
Marketing start 2024-03-22
Substance IBUPROFEN; FAMOTIDINE
Active strength 800; 26.6 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 2026-09-14 22:38:34 2026-08 A203658-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2024-03-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203658-001 IBUPROFEN AND FAMOTIDINE 26.6MG;800MG TABLET / ORAL AB 2024-03-22 caaa826d4ba7…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# 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 famotidine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 800 mg/1 FAMOTIDINE 26.6 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 49884-366-09 Ibuprofen and famotidine 90 in 1 BOTTLE TABLET 90 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-366 IBUPROFEN AND FAMOTIDINE TABLET [ENDO USA, INC.] 9 Current NDC, 1 package rows 20240523_b6895176-efb1-472e-8b6f-2987e8e67684.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 49884-366-09 49884036609 90 TABLET in 1 BOTTLE (49884-366-09) 90 tablet 2024-03-22 No No Current