Home NDC 70748-327 Raltegravir
Product NDC 70748-327
11-digit product format 707480327
Labeler code 70748
Product ID 70748-327_36653fbc-5ca3-43ac-af3b-633712765a3a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Raltegravir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA217990
Marketing category ANDA
Marketing start 2026-10-14
Substance RALTEGRAVIR POTASSIUM
Active strength 600 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 44 .
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 A217990-001 RALTEGRAVIR POTASSIUM RALTEGRAVIR POTASSIUM EQ 600MG BASE TABLET / ORAL AB 2025-05-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217990-001 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 2026-10-15 13:18:30 2026-09 A217990-001 RALTEGRAVIR POTASSIUM EQ 600MG BASE TABLET / ORAL AB 2025-05-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 A217990-001 RALTEGRAVIR POTASSIUM EQ 600MG BASE TABLET / ORAL AB 2025-05-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217990-001 RALTEGRAVIR POTASSIUM EQ 600MG BASE TABLET / ORAL AB 2025-05-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217990-001 RALTEGRAVIR POTASSIUM EQ 600MG BASE TABLET / ORAL AB 2025-05-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217990-001 RALTEGRAVIR POTASSIUM EQ 600MG BASE TABLET / ORAL AB 2025-05-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217990-001 RALTEGRAVIR POTASSIUM EQ 600MG BASE TABLET / ORAL AB 2025-05-06 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217990-001 RALTEGRAVIR POTASSIUM EQ 600MG BASE TABLET / ORAL AB 2025-05-06 a50c72e98297…
Observed Orange Book normalized TE history# 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 600 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70748-327-07 70748032707 60 TABLET, FILM COATED in 1 BOTTLE (70748-327-07) 2026-10-14 No No Current