Home NDC 81646-113-43 Ibuprofen
Product NDC 81646-113
Requested package NDC 81646-113-43
11-digit product format 816460113
Labeler code 81646
Product ID 81646-113_483e7336-2c5b-4468-b754-24b9be314992
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler PINNACLE PHARMA LLC
Application ANDA076925
Marketing category ANDA
Marketing start 2004-12-08
Marketing end 0000-00-00
Substance IBUPROFEN
Active strength 100 mg/5mL
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A076925-001 IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076925-001 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.
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 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076925-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2004-09-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81646-113-20 Ibuprofen 20 mL in 1 CUP, UNIT-DOSE SUSPENSION 20 1 81646-113-43 Ibuprofen 1 in 1 CARTON SUSPENSION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81646-113 IBUPROFEN SUSPENSION [PINNACLE PHARMA LLC] 1 Legacy NDC, 2 package rows 20210513_d40a898e-524a-4f6e-83a7-bab4ce5218d1.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 Marketing start Marketing end Sample Exclude flag Status 81646-113-43 81646011343 1 CUP, UNIT-DOSE in 1 CARTON (81646-113-43) > 20 mL in 1 CUP, UNIT-DOSE (81646-113-20) 2004-12-08 0000-00-00 No No Current