JANUVIA

Product NDC: 55154-5042
11-digit product format: 551545042
Labeler code: 55154
Product ID: 55154-5042_a4967ec8-0c3d-4e7f-a271-b8043bcac46b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sitagliptin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: NDA021995
Marketing category: NDA
Marketing start: 2006-10-16
Substance: SITAGLIPTIN PHOSPHATE
Active strength: 100 mg/1
Pharmacologic classes: Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021995-001	JANUVIA	SITAGLIPTIN PHOSPHATE	EQ 25MG BASE	TABLET / ORAL	AB	RLD	2006-10-16
N021995-002	JANUVIA	SITAGLIPTIN PHOSPHATE	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2006-10-16
N021995-003	JANUVIA	SITAGLIPTIN PHOSPHATE	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	2006-10-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N021995-001	AB
N021995-002	AB
N021995-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status
N021995-001	7326708	2026-11-24	U-802	Drug substance, Drug product
N021995-001	7326708*PED	2027-05-24		Pediatric extension
N021995-002	7326708	2026-11-24	U-802	Drug substance, Drug product
N021995-002	7326708*PED	2027-05-24		Pediatric extension
N021995-003	7326708	2026-11-24	U-802	Drug substance, Drug product
N021995-003	7326708*PED	2027-05-24		Pediatric extension

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 4 · 126 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
2026-08-18 06:07:40	2026-07	N021995-001	JANUVIA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	2006-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021995-002	JANUVIA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2006-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021995-003	JANUVIA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	2006-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021995-001	JANUVIA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	2006-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021995-002	JANUVIA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2006-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021995-003	JANUVIA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	2006-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021995-001	JANUVIA	EQ 25MG BASE	TABLET / ORAL		RLD	2006-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021995-002	JANUVIA	EQ 50MG BASE	TABLET / ORAL		RLD	2006-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021995-003	JANUVIA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2006-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021995-001	JANUVIA	EQ 25MG BASE	TABLET / ORAL		RLD	2006-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021995-002	JANUVIA	EQ 50MG BASE	TABLET / ORAL		RLD	2006-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021995-003	JANUVIA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2006-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021995-001	JANUVIA	EQ 25MG BASE	TABLET / ORAL		RLD	2006-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021995-002	JANUVIA	EQ 50MG BASE	TABLET / ORAL		RLD	2006-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021995-003	JANUVIA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2006-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021995-001	JANUVIA	EQ 25MG BASE	TABLET / ORAL		RLD	2006-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021995-002	JANUVIA	EQ 50MG BASE	TABLET / ORAL		RLD	2006-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021995-003	JANUVIA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2006-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021995-001	JANUVIA	EQ 25MG BASE	TABLET / ORAL		RLD	2006-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021995-002	JANUVIA	EQ 50MG BASE	TABLET / ORAL		RLD	2006-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021995-003	JANUVIA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2006-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021995-001	JANUVIA	EQ 25MG BASE	TABLET / ORAL		RLD	2006-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021995-002	JANUVIA	EQ 50MG BASE	TABLET / ORAL		RLD	2006-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021995-003	JANUVIA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2006-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021995-001	JANUVIA	EQ 25MG BASE	TABLET / ORAL		RLD	2006-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021995-002	JANUVIA	EQ 50MG BASE	TABLET / ORAL		RLD	2006-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021995-003	JANUVIA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2006-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021995-001	JANUVIA	EQ 25MG BASE	TABLET / ORAL		RLD	2006-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021995-002	JANUVIA	EQ 50MG BASE	TABLET / ORAL		RLD	2006-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021995-003	JANUVIA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2006-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021995-001	JANUVIA	EQ 25MG BASE	TABLET / ORAL		RLD	2006-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021995-002	JANUVIA	EQ 50MG BASE	TABLET / ORAL		RLD	2006-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021995-003	JANUVIA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2006-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021995-001	JANUVIA	EQ 25MG BASE	TABLET / ORAL		RLD	2006-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021995-002	JANUVIA	EQ 50MG BASE	TABLET / ORAL		RLD	2006-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021995-003	JANUVIA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2006-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021995-001	JANUVIA	EQ 25MG BASE	TABLET / ORAL		RLD	2006-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021995-002	JANUVIA	EQ 50MG BASE	TABLET / ORAL		RLD	2006-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021995-003	JANUVIA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2006-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021995-001	JANUVIA	EQ 25MG BASE	TABLET / ORAL		RLD	2006-10-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021995-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021995-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021995-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021995-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021995-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021995-003	AB	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021995-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021995-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021995-003	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 17 · 657 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2026-08-18 06:07:40	2026-07	N021995-001	7326708	2026-11-24	U-802	Drug substance, Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021995-001	7326708*PED	2027-05-24		Pediatric extension	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021995-002	7326708	2026-11-24	U-802	Drug substance, Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021995-002	7326708*PED	2027-05-24		Pediatric extension	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021995-003	7326708	2026-11-24	U-802	Drug substance, Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021995-003	7326708*PED	2027-05-24		Pediatric extension	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021995-001	7326708	2026-11-24	U-802	Drug substance, Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021995-001	7326708*PED	2027-05-24		Pediatric extension	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021995-002	7326708	2026-11-24	U-802	Drug substance, Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021995-002	7326708*PED	2027-05-24		Pediatric extension	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021995-003	7326708	2026-11-24	U-802	Drug substance, Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021995-003	7326708*PED	2027-05-24		Pediatric extension	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021995-001	7326708	2026-11-24	U-802	Drug substance, Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021995-001	7326708*PED	2027-05-24		Pediatric extension	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021995-002	7326708	2026-11-24	U-802	Drug substance, Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021995-002	7326708*PED	2027-05-24		Pediatric extension	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021995-003	7326708	2026-11-24	U-802	Drug substance, Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021995-003	7326708*PED	2027-05-24		Pediatric extension	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021995-001	7326708	2026-11-24	U-802	Drug substance, Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021995-001	7326708*PED	2027-05-24		Pediatric extension	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021995-002	7326708	2026-11-24	U-802	Drug substance, Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021995-002	7326708*PED	2027-05-24		Pediatric extension	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021995-003	7326708	2026-11-24	U-802	Drug substance, Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021995-003	7326708*PED	2027-05-24		Pediatric extension	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021995-001	7326708	2026-11-24	U-802	Drug substance, Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021995-001	7326708*PED	2027-05-24		Pediatric extension	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021995-002	7326708	2026-11-24	U-802	Drug substance, Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021995-002	7326708*PED	2027-05-24		Pediatric extension	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021995-003	7326708	2026-11-24	U-802	Drug substance, Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021995-003	7326708*PED	2027-05-24		Pediatric extension	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021995-001	7326708	2026-11-24	U-802	Drug substance, Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021995-001	7326708*PED	2027-05-24		Pediatric extension	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021995-002	7326708	2026-11-24	U-802	Drug substance, Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021995-002	7326708*PED	2027-05-24		Pediatric extension	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021995-003	7326708	2026-11-24	U-802	Drug substance, Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021995-003	7326708*PED	2027-05-24		Pediatric extension	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021995-001	7326708	2026-11-24	U-802	Drug substance, Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021995-001	7326708*PED	2027-05-24		Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021995-002	7326708	2026-11-24	U-802	Drug substance, Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021995-002	7326708*PED	2027-05-24		Pediatric extension	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 7 · 279 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021995-001	M-187	2023-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021995-001	PED	2024-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021995-002	M-187	2023-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021995-002	PED	2024-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021995-003	M-187	2023-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021995-003	PED	2024-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021995-001	M-187	2023-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021995-001	PED	2024-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021995-002	M-187	2023-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021995-002	PED	2024-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021995-003	M-187	2023-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021995-003	PED	2024-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021995-001	M-187	2023-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021995-001	PED	2024-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021995-002	M-187	2023-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021995-002	PED	2024-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021995-003	M-187	2023-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021995-003	PED	2024-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021995-001	M-187	2023-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021995-001	PED	2024-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021995-002	M-187	2023-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021995-002	PED	2024-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021995-003	M-187	2023-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021995-003	PED	2024-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021995-001	M-187	2023-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021995-001	PED	2024-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021995-002	M-187	2023-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021995-002	PED	2024-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021995-003	M-187	2023-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021995-003	PED	2024-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021995-001	M-187	2023-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021995-001	PED	2024-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021995-002	M-187	2023-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021995-002	PED	2024-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021995-003	M-187	2023-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021995-003	PED	2024-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021995-001	M-187	2023-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021995-001	PED	2024-06-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021995-002	M-187	2023-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021995-002	PED	2024-06-04	`301d65b070ca…`

Additional Listing Data#

Finished product: Yes
Brand name base: JANUVIA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SITAGLIPTIN PHOSPHATE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TS63EW8X6F	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
665036	Internal RxNorm lookup
2709603	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
9d558f96-24a5-4788-8933-38256c17384b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
19a549d9-1cb9-4833-ba02-91db3dcb07ba	Product name	1	20251107
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
ff2e6e82-af62-4b84-b1ca-09520f6c5a79	Product name	1	20250630
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
fd232072-39c4-4416-9b66-265d18a7bd93	Product name	1	20180306
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
9fa860f8-41a8-caa8-93ae-a5bdc7b15db7	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55154-5042-8	JANUVIA	1350 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1350		15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SITAGLIPTIN PHOSPHATE	ACTIVE INGREDIENT	TS63EW8X6F	JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]	3
SITAGLIPTIN	ACTIVE MOIETY	QFP0P1DV7Z	JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]	3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]	3
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]	3
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]	3
talc	INACTIVE INGREDIENT	7SEV7J4R1U	JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]	3
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-5042	JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]	14	Current NDC, Legacy NDC, 1 package rows	20240928_9d558f96-24a5-4788-8933-38256c17384b.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JANUVIA	SITAGLIPTIN	A-S Medication Solutions	62c4f58b-2b28-4825-aeb6-213ab9b7a026	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021995 application number: NDA021995
JANUVIA	SITAGLIPTIN	A-S Medication Solutions	194c3718-5eb5-4cf5-85d0-2bb1ed8293b8	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021995 application number: NDA021995
JANUVIA	SITAGLIPTIN	A-S Medication Solutions	4a758211-8af1-449b-9a10-f3d67d7ec8b6	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021995 application number: NDA021995
JANUVIA	SITAGLIPTIN	A-S Medication Solutions	1b03c82f-b52e-4092-b9dc-f2c9b0d6ab40	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021995 application number: NDA021995
JANUVIA	SITAGLIPTIN	A-S Medication Solutions	eb81a45f-05b8-49de-99ce-5089bd360d9b	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021995 application number: NDA021995
JANUVIA	SITAGLIPTIN	Cardinal Health 107, LLC	9d558f96-24a5-4788-8933-38256c17384b	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021995 application number: NDA021995 ndc (product): 55154-5042
JANUVIA	SITAGLIPTIN	Cardinal Health 107, LLC	39253ddd-0245-43b1-ad28-d5923983afb4	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021995 application number: NDA021995
JANUVIA	SITAGLIPTIN	Merck Sharp & Dohme LLC	f85a48d0-0407-4c50-b0fa-7673a160bf01	2024-11-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021995 application number: NDA021995
JANUVIA	SITAGLIPTIN	A-S Medication Solutions	e2e576e6-6181-4178-b989-61d0e795e559	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021995 application number: NDA021995

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TS63EW8X6F	SITAGLIPTIN PHOSPHATE	654671-77-9	SITAGLIPTIN PHOSPHATE
QFP0P1DV7Z	SITAGLIPTIN	486460-32-6	sitagliptin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
665036	Januvia 100 MG Oral Tablet	PSN	9d558f96-24a5-4788-8933-38256c17384b	15
2709603	SITagliptin phosphate 100 MG Oral Tablet	PSN	9d558f96-24a5-4788-8933-38256c17384b	15
665036	sitagliptin phosphate 100 MG Oral Tablet [Januvia]	SBD	9d558f96-24a5-4788-8933-38256c17384b	15
2709603	sitagliptin phosphate 100 MG Oral Tablet	SCD	9d558f96-24a5-4788-8933-38256c17384b	15
665036	Januvia 100 MG (as sitagliptin phosphate monohydrate 128.5 MG) Oral Tablet	SY	9d558f96-24a5-4788-8933-38256c17384b	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-5042-8	55154504208	1350 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-5042-8)	2006-10-16	0000-00-00	No	No	Current