Home NDC 66993-490 Ibuprofen Lysine
Product NDC 66993-490
11-digit product format 669930490
Labeler code 66993
Product ID 66993-490_67ff91a5-d5cb-4a5e-a349-07f99b1e7af0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ibuprofen lysine
Dosage form SOLUTION
Route INTRAVENOUS
Labeler Prasco Laboratories
Application NDA021903
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2016-04-14
Substance IBUPROFEN LYSINE
Active strength 10 mg/mL
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 N021903-001 NEOPROFEN IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021903-001 AP
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11
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 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021903-001 NEOPROFEN EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-04-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 59 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021903-001 6342530 2020-11-14 U-1127 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021903-001 6342530 2020-11-14 U-794 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021903-001 6344479 2021-03-20 U-794 Drug substance, Drug product, Delist requested 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021903-001 6342530 2020-11-14 U-1127 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021903-001 6342530 2020-11-14 U-794 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021903-001 6344479 2021-03-20 U-794 Drug substance, Drug product, Delist requested 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021903-001 6342530 2020-11-14 U-1127 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021903-001 6342530 2020-11-14 U-794 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021903-001 6344479 2021-03-20 U-794 Drug substance, Drug product, Delist requested c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021903-001 6342530 2020-11-14 U-1127 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021903-001 6342530 2020-11-14 U-794 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021903-001 6344479 2021-03-20 U-794 Drug substance, Drug product, Delist requested 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021903-001 8415337 2032-03-02 Drug substance, Drug product 2013-04-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021903-001 6342530 2020-11-14 U-1127 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021903-001 6342530 2020-11-14 U-794 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021903-001 6344479 2021-03-20 U-794 Drug substance, Drug product, Delist requested b00525d2431f…
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen Lysine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN LYSINE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N01ORX9D6S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1747294 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 66993-490-36 Ibuprofen Lysine 3 in 1 CARTON SOLUTION 3 12 66993-490-36 Ibuprofen Lysine 2 mL in 1 VIAL SOLUTION 2 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66993-490 IBUPROFEN LYSINE SOLUTION [PRASCO LABORATORIES] 11 Current NDC, Legacy NDC, 2 package rows 20240106_307431c7-12de-21e5-e054-00144ff88e88.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 Units Marketing start Marketing end Sample Exclude flag Status 66993-490-36 66993049036 3 VIAL in 1 CARTON (66993-490-36) / 2 mL in 1 VIAL 3 vial 2016-04-14 0000-00-00 No No Current