Home NDC 0121-0833 Childrens Ibuprofen Oral Suspension
Product NDC 0121-0833
11-digit product format 001210833
Labeler code 0121
Product ID 0121-0833_70b3589f-fd88-4a73-b758-0d456422bd27
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA214789
Marketing category ANDA
Marketing start 2025-08-01
Substance IBUPROFEN
Active strength 100 mg/5mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], 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 A214789-001 IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2024-11-08
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 A214789-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2024-11-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214789-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2024-11-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214789-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2024-11-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214789-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2024-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214789-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2024-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214789-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2024-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214789-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2024-11-08 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214789-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2024-11-08 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Childrens Ibuprofen Oral Suspension
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197803 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 0121-0833-00 Childrens Ibuprofen Oral Suspension 10 in 1 CASE SUSPENSION 10 8 0121-0833-00 Childrens Ibuprofen Oral Suspension 10 in 1 TRAY SUSPENSION 10 8 0121-0833-05 Childrens Ibuprofen Oral Suspension 5 mL in 1 CUP, UNIT-DOSE SUSPENSION 5 8 0121-0833-40 Childrens Ibuprofen Oral Suspension 4 in 1 CASE SUSPENSION 4 8 0121-0833-40 Childrens Ibuprofen Oral Suspension 10 in 1 TRAY SUSPENSION 10 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-0833 CHILDRENS IBUPROFEN ORAL SUSPENSION (IBUPROFEN) SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA] 5 Current NDC, 5 package rows 20250507_c26cefe0-182a-4b03-baeb-b3eb2e0e2267.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 0121-0833-00 00121083300 10 TRAY in 1 CASE (0121-0833-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0833-05) 10 tray 2025-08-01 No No Current 0121-0833-05 00121083305 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 0121-0833-40 00121083340 4 TRAY in 1 CASE (0121-0833-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0833-05) 4 tray 2025-08-01 No No Current