Home NDC 17856-5309-9 Ibuprofen
Product NDC 17856-5309
Requested package NDC 17856-5309-9
11-digit product format 178565309
Labeler code 17856
Product ID 17856-5309_34f37e2c-ba78-120a-e063-6294a90aa750
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA074937
Marketing category ANDA
Marketing start 1999-02-07
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 A074937-001 CHILDREN'S IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22
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.
Product history page 1 of 2 · 41 observed 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 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-5309 IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORP.] 12 Current NDC, Legacy NDC, 10 package rows 20250514_230914e6-fe0c-45be-8b2e-e066c71d004c.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 5 · 82 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 17856-5309-9 17856530909 1 mL in 1 SYRINGE (17856-5309-9) 1 ml 2021-01-28 0000-00-00 No No Current