Home NDC 50090-1085 ISENTRESS
Product NDC 50090-1085
11-digit product format 500901085
Labeler code 50090
Product ID 50090-1085_fa8200b3-64ad-4ba4-a708-7a9b564d2ac8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name RALTEGRAVIR
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application NDA022145
Marketing category NDA
Marketing start 2007-10-12
Substance RALTEGRAVIR POTASSIUM
Active strength 400 mg/1
Pharmacologic classes HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022145-001 ISENTRESS RALTEGRAVIR POTASSIUM EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 N022145-002 ISENTRESS HD RALTEGRAVIR POTASSIUM EQ 600MG BASE TABLET / ORAL AB RLD, RS 2017-05-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022145-002 AB
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022145-001 8852632 2028-01-28 U-257 Drug substance, Drug product 2023-03-27 N022145-001 7754731 2029-03-11 U-257 Drug substance, Drug product N022145-001 7754731*PED 2029-09-11 Pediatric extension N022145-001 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 N022145-002 7754731 2029-03-11 U-257 Drug substance, Drug product 2017-06-23 N022145-002 7754731*PED 2029-09-11 Pediatric extension N022145-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 N022145-002 9649311 2030-10-21 Drug product 2017-06-23 N022145-002 9649311*PED 2031-04-21 Pediatric extension N022145-002 10772888 2032-03-30 U-1663 2020-10-27
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 3 · 82 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 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL AB RLD, RS 2017-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL AB RLD, RS 2017-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL AB RLD, RS 2017-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL AB RLD, RS 2007-10-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 17 · 674 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 N022145-001 8852632 2028-01-28 U-257 Drug substance, Drug product 2023-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-001 7754731 2029-03-11 U-257 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-001 7754731*PED 2029-09-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-001 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 7754731 2029-03-11 U-257 Drug substance, Drug product 2017-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 7754731*PED 2029-09-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 9649311 2030-10-21 Drug product 2017-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 9649311*PED 2031-04-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 10772888 2032-03-30 U-1663 2020-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-001 8852632 2028-01-28 U-257 Drug substance, Drug product 2023-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-001 7754731 2029-03-11 U-257 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-001 7754731*PED 2029-09-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-001 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 7754731 2029-03-11 U-257 Drug substance, Drug product 2017-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 7754731*PED 2029-09-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 9649311 2030-10-21 Drug product 2017-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 9649311*PED 2031-04-21 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 10772888 2032-03-30 U-1663 2020-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022145-001 8852632 2028-01-28 U-257 Drug substance, Drug product 2023-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-001 7754731 2029-03-11 U-257 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-001 7754731*PED 2029-09-11 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-001 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-002 7754731 2029-03-11 U-257 Drug substance, Drug product 2017-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-002 7754731*PED 2029-09-11 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-002 9649311 2030-10-21 Drug product 2017-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-002 9649311*PED 2031-04-21 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-002 10772888 2032-03-30 U-1663 2020-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022145-001 8852632 2028-01-28 U-257 Drug substance, Drug product 2023-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022145-001 7754731 2029-03-11 U-257 Drug substance, Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022145-001 7754731*PED 2029-09-11 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022145-001 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022145-002 7754731 2029-03-11 U-257 Drug substance, Drug product 2017-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022145-002 7754731*PED 2029-09-11 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022145-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022145-002 9649311 2030-10-21 Drug product 2017-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022145-002 9649311*PED 2031-04-21 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022145-002 10772888 2032-03-30 U-1663 2020-10-27 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 54 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ISENTRESS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RALTEGRAVIR POTASSIUM 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 43Y000U234 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 744842 Internal RxNorm lookup 744846 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 50090-1085-0 ISENTRESS 60 in 1 BOTTLE TABLET, FILM COATED 60 25 50090-1085-1 ISENTRESS 8 in 1 BOTTLE TABLET, FILM COATED 8 25 50090-1085-2 ISENTRESS 6 in 1 BOTTLE TABLET, FILM COATED 6 25
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-1085 ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 25 Current NDC, Legacy NDC, 3 package rows 20231210_7e659505-c902-4906-9461-1cc83e2236d2.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 · 4 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 50090-1085-0 50090108500 60 TABLET, FILM COATED in 1 BOTTLE (50090-1085-0) 2014-11-28 0000-00-00 No No Current 50090-1085-1 50090108501 8 TABLET, FILM COATED in 1 BOTTLE (50090-1085-1) 2014-11-28 0000-00-00 No No Current 50090-1085-2 50090108502 6 TABLET, FILM COATED in 1 BOTTLE (50090-1085-2) 2018-03-16 0000-00-00 No No Current