Home NDC 31722-584 Raltegravir
Product NDC 31722-584
11-digit product format 317220584
Labeler code 31722
Product ID 31722-584_55c7c6ef-cc60-1f7e-e063-6294a90ac6be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Raltegravir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA203540
Marketing category ANDA
Marketing start 2024-12-19
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A203540-001 RALTEGRAVIR POTASSIUM RALTEGRAVIR POTASSIUM EQ 400MG BASE TABLET / ORAL AB 2024-12-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203540-001 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 2026-09-14 22:38:34 2026-08 A203540-001 RALTEGRAVIR POTASSIUM EQ 400MG BASE TABLET / ORAL AB 2024-12-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203540-001 RALTEGRAVIR POTASSIUM EQ 400MG BASE TABLET / ORAL 2024-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203540-001 RALTEGRAVIR POTASSIUM EQ 400MG BASE TABLET / ORAL 2024-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203540-001 RALTEGRAVIR POTASSIUM EQ 400MG BASE TABLET / ORAL 2024-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203540-001 RALTEGRAVIR POTASSIUM EQ 400MG BASE TABLET / ORAL 2024-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203540-001 RALTEGRAVIR POTASSIUM EQ 400MG BASE TABLET / ORAL 2024-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203540-001 RALTEGRAVIR POTASSIUM EQ 400MG BASE TABLET / ORAL 2024-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203540-001 RALTEGRAVIR POTASSIUM EQ 400MG BASE TABLET / ORAL AB 2024-12-19 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A203540-001 RALTEGRAVIR POTASSIUM EQ 400MG BASE TABLET / ORAL 2024-12-19 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A203540-001 AB 1 84e616aacf4f…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203540-001 AB 1 03ed91905a0d…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Raltegravir
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 744842 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 31722-584-60 31722058460 60 TABLET, FILM COATED in 1 BOTTLE (31722-584-60) 2024-12-19 No No Current