Raltegravir

Product NDC: 70748-327
Requested package NDC: 70748-327-07
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 45.

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

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
A217990-001	PC	2027-05-01

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	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	A217990-001	RALTEGRAVIR POTASSIUM	EQ 600MG BASE	TABLET / ORAL	AB	2025-05-06	`d4dbc9d85df4…`
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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-11-14 07:37:17	2026-10	A217990-001	AB	1	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A217990-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A217990-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217990-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217990-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217990-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217990-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217990-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-11-14 07:37:17	2026-10	A217990-001	PC	2027-05-01	`d4dbc9d85df4…`

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

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
1924313	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e9661839-bd2e-464f-a6df-6407b4a742b4	Available on FDA.report

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
43Y000U234	RALTEGRAVIR POTASSIUM	871038-72-1	RALTEGRAVIR POTASSIUM
22VKV8053U	RALTEGRAVIR	518048-05-0	Raltegravir

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1235585	raltegravir potassium	raltegravir potassium	PIN Active

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Raltegravir	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2026-10-12	HUMAN PRESCRIPTION DRUG LABEL	2