Home NDC 69452-469-22 Acetaminophen and Ibuprofen
Product NDC 69452-469
Requested package NDC 69452-469-22
11-digit product format 694520469
Labeler code 69452
Product ID 69452-469_4834b0ac-3df4-e9af-e063-6394a90a3ab2
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler BIONPHARMA INC.
Application ANDA216999
Marketing category ANDA
Marketing start 2026-01-13
Substance ACETAMINOPHEN; IBUPROFEN
Active strength 250; 125 mg/1; 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 2027-12-31
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 A216999-001 ACETAMINOPHEN AND IBUPROFEN ACETAMINOPHEN; IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01
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 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216999-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-08-01 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Acetaminophen and Ibuprofen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 250 mg/1 ACETAMINOPHEN 125 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 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2387532 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 69452-469-22 Acetaminophen and Ibuprofen 120 in 1 BOTTLE TABLET, FILM COATED 120 1 69452-469-22 Acetaminophen and Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 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 · 12 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 69452-469-22 69452046922 1 BOTTLE in 1 CARTON (69452-469-22) / 120 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2026-01-13 No No Current