Home NDC 64380-997 Ibuprofen
Product NDC 64380-997
11-digit product format 643800997
Labeler code 64380
Product ID 64380-997_5f919f0a-7dad-405f-b383-dcde4091b5ec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA215311
Marketing category ANDA
Marketing start 2023-09-19
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A215311-001 IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215311-001 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 2026-08-18 06:07:40 2026-07 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2022-05-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2022-05-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2022-05-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2022-05-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215311-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL AB 2022-05-27 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen
Listing expiration 2027-12-31 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 64380-997-01 Ibuprofen 5 mL in 1 CUP SUSPENSION 5 7 64380-997-02 Ibuprofen 10 in 1 TRAY SUSPENSION 10 7 64380-997-03 Ibuprofen 1 in 1 CARTON SUSPENSION 1 7 64380-997-03 Ibuprofen 118 mL in 1 BOTTLE SUSPENSION 118 7 64380-997-04 Ibuprofen 473 mL in 1 BOTTLE SUSPENSION 473 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-997 IBUPROFEN SUSPENSION [STRIDES PHARMA SCIENCE LIMITED] 6 Current NDC, Legacy NDC, 5 package rows 20231012_38ebacc3-378f-483e-babc-76119677e7df.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 Marketing end Sample Exclude flag Status 64380-997-01 64380099701 5 mL in 1 CUP 5 ml Historical 64380-997-02 64380099702 10 in 1 TRAY Historical 64380-997-03 64380099703 1 BOTTLE in 1 CARTON (64380-997-03) / 118 mL in 1 BOTTLE 1 bottle 2023-09-19 0000-00-00 No No Current 64380-997-04 64380099704 473 mL in 1 BOTTLE (64380-997-04) 473 ml 2023-09-19 0000-00-00 No No Current