Yorvipath

Product NDC: 73362-101
11-digit product format: 733620101
Labeler code: 73362
Product ID: 73362-101_eb81bad9-a369-4eeb-a69e-6920924381b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Palopegteriparatide
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Ascendis Pharma, Endocrinology, Inc.
Application: NDA216490
Marketing category: NDA
Marketing start: 2024-08-09
Substance: PALOPEGTERIPARATIDE
Active strength: 294 ug/.98mL
Pharmacologic classes: Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]
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 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	RLD / RS	Approval date
N216490-001	YORVIPATH	PALOPEGTERIPARATIDE	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09
N216490-002	YORVIPATH	PALOPEGTERIPARATIDE	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09
N216490-003	YORVIPATH	PALOPEGTERIPARATIDE	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09

Orange Book patents#

Current patent rows page 1 of 1 · 27 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216490-001	8906847	2031-04-30	U-3982	Drug substance, Drug product	2024-09-05
N216490-001	11590207	2037-09-28	U-3982		2024-09-05
N216490-001	11759504	2037-09-28		Drug product	2024-09-05
N216490-001	11857603	2037-09-28	U-3982		2024-09-05
N216490-001	11890326	2037-09-28		Drug substance, Drug product	2024-09-05
N216490-001	11918628	2037-09-28		Drug substance, Drug product	2024-09-05
N216490-001	12295989	2037-09-28	U-3982		2025-05-29
N216490-001	12453778	2037-09-28	U-3982		2025-11-12
N216490-001	12403182	2042-11-12	U-3982	Drug product	2025-09-05
N216490-002	8906847	2031-04-30	U-3982	Drug substance, Drug product	2024-09-05
N216490-002	11590207	2037-09-28	U-3982		2024-09-05
N216490-002	11759504	2037-09-28		Drug product	2024-09-05
N216490-002	11857603	2037-09-28	U-3982		2024-09-05
N216490-002	11890326	2037-09-28		Drug substance, Drug product	2024-09-05
N216490-002	11918628	2037-09-28		Drug substance, Drug product	2024-09-05
N216490-002	12295989	2037-09-28	U-3982		2025-05-29
N216490-002	12453778	2037-09-28	U-3982		2025-11-12
N216490-002	12403182	2042-11-12	U-3982	Drug product	2025-09-05
N216490-003	8906847	2031-04-30	U-3982	Drug substance, Drug product	2024-09-05
N216490-003	11590207	2037-09-28	U-3982		2024-09-05
N216490-003	11759504	2037-09-28		Drug product	2024-09-05
N216490-003	11857603	2037-09-28	U-3982		2024-09-05
N216490-003	11890326	2037-09-28		Drug substance, Drug product	2024-09-05
N216490-003	11918628	2037-09-28		Drug substance, Drug product	2024-09-05
N216490-003	12295989	2037-09-28	U-3982		2025-05-29
N216490-003	12453778	2037-09-28	U-3982		2025-11-12
N216490-003	12403182	2042-11-12	U-3982	Drug product	2025-09-05

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216490-001	NCE	2029-08-09
N216490-001	ODE-492	2031-08-09
N216490-002	NCE	2029-08-09
N216490-002	ODE-492	2031-08-09
N216490-003	NCE	2029-08-09
N216490-003	ODE-492	2031-08-09

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD	2024-08-09	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216490-001	YORVIPATH	EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216490-002	YORVIPATH	EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216490-003	YORVIPATH	EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2024-08-09	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 237 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216490-001	8906847	2031-04-30	U-3982	Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	11590207	2037-09-28	U-3982		2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	11759504	2037-09-28		Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	11857603	2037-09-28	U-3982		2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	11890326	2037-09-28		Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	11918628	2037-09-28		Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	12295989	2037-09-28	U-3982		2025-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	12453778	2037-09-28	U-3982		2025-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	12403182	2042-11-12	U-3982	Drug product	2025-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	8906847	2031-04-30	U-3982	Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	11590207	2037-09-28	U-3982		2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	11759504	2037-09-28		Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	11857603	2037-09-28	U-3982		2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	11890326	2037-09-28		Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	11918628	2037-09-28		Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	12295989	2037-09-28	U-3982		2025-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	12453778	2037-09-28	U-3982		2025-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	12403182	2042-11-12	U-3982	Drug product	2025-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	8906847	2031-04-30	U-3982	Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	11590207	2037-09-28	U-3982		2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	11759504	2037-09-28		Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	11857603	2037-09-28	U-3982		2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	11890326	2037-09-28		Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	11918628	2037-09-28		Drug substance, Drug product	2024-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	12295989	2037-09-28	U-3982		2025-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	12453778	2037-09-28	U-3982		2025-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	12403182	2042-11-12	U-3982	Drug product	2025-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216490-001	8906847	2031-04-30	U-3982	Drug substance, Drug product	2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	11590207	2037-09-28	U-3982		2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	11759504	2037-09-28		Drug product	2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	11857603	2037-09-28	U-3982		2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	11890326	2037-09-28		Drug substance, Drug product	2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	11918628	2037-09-28		Drug substance, Drug product	2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	12295989	2037-09-28	U-3982		2025-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	12453778	2037-09-28	U-3982		2025-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	12403182	2042-11-12	U-3982	Drug product	2025-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-002	8906847	2031-04-30	U-3982	Drug substance, Drug product	2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-002	11590207	2037-09-28	U-3982		2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-002	11759504	2037-09-28		Drug product	2024-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-002	11857603	2037-09-28	U-3982		2024-09-05	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N216490-001	NCE	2029-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-001	ODE-492	2031-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	NCE	2029-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-002	ODE-492	2031-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	NCE	2029-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216490-003	ODE-492	2031-08-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216490-001	NCE	2029-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-001	ODE-492	2031-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-002	NCE	2029-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-002	ODE-492	2031-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-003	NCE	2029-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216490-003	ODE-492	2031-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-001	NCE	2029-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-001	ODE-492	2031-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-002	NCE	2029-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-002	ODE-492	2031-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-003	NCE	2029-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216490-003	ODE-492	2031-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216490-001	NCE	2029-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216490-001	ODE-492	2031-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216490-002	NCE	2029-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216490-002	ODE-492	2031-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216490-003	NCE	2029-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216490-003	ODE-492	2031-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-001	NCE	2029-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-001	ODE-492	2031-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-002	NCE	2029-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-002	ODE-492	2031-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-003	NCE	2029-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216490-003	ODE-492	2031-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-001	NCE	2029-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-001	ODE-492	2031-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-002	NCE	2029-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-002	ODE-492	2031-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-003	NCE	2029-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216490-003	ODE-492	2031-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216490-001	NP	2027-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216490-001	ODE-492	2031-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216490-002	NP	2027-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216490-002	ODE-492	2031-08-09	`03ed91905a0d…`

Additional Listing Data#

Finished product: Yes
Brand name base: Yorvipath
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PALOPEGTERIPARATIDE	294 ug/.98mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G2N64C3385	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2693637	Internal RxNorm lookup
2693643	Internal RxNorm lookup
2693645	Internal RxNorm lookup
2693646	Internal RxNorm lookup
2693647	Internal RxNorm lookup
2693648	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
a1fa23fd-c434-443e-9a17-5750578c8602	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b921a6be-c897-e1d4-f6d7-f4df8c2a7a6a	Product name	2	20250731
bc54407b-4c2b-4714-a018-cf90828b0cb1	Product name	1	20250317
25117fd6-247a-42b6-bd01-89f9877d0f51	Product name	1	20200304

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
73362-101-01	Yorvipath	2 in 1 CARTON	INJECTION, SOLUTION	2	7
73362-101-02	Yorvipath	1 in 1 BOX	INJECTION, SOLUTION	1	7
73362-101-03	Yorvipath	0.98 mL in 1 CARTRIDGE	INJECTION, SOLUTION	0.98	7
73362-101-03	Yorvipath	1 in 1 SYRINGE	INJECTION, SOLUTION	1	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73362-101-01	ML - Milliliter	73362-101	b767f007-530d-4ac4-84d6-bc509b871b0d	1	2024-10-04
73362-101-03	ML - Milliliter	73362-101	9665c3ab-7b49-4a00-a4c6-073cec62acb0	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73362-101	YORVIPATH (PALOPEGTERIPARATIDE) INJECTION, SOLUTION [ASCENDIS PHARMA, ENDOCRINOLOGY, INC.]	4	Current NDC, 4 package rows	20241019_a1fa23fd-c434-443e-9a17-5750578c8602.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Yorvipath	PALOPEGTERIPARATIDE	Ascendis Pharma, Endocrinology, Inc.	a1fa23fd-c434-443e-9a17-5750578c8602	2026-08-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216490 application number: NDA216490 ndc (product): 73362-101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2693637	palopegteriparatide 168 MCG in 0.56 ML Pen Injector	PSN	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693645	palopegteriparatide 294 MCG in 0.98 ML Pen Injector	PSN	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693647	palopegteriparatide 420 MCG in 1.4 ML Pen Injector	PSN	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693643	Yorvipath 168 MCG in 0.56 ML Pen Injector	PSN	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693646	Yorvipath 294 MCG in 0.98 ML Pen Injector	PSN	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693648	Yorvipath 420 MCG in 1.4 ML Pen Injector	PSN	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693643	0.56 ML teriparatide 0.3 MG/ML Pen Injector [Yorvipath]	SBD	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693646	0.98 ML teriparatide 0.3 MG/ML Pen Injector [Yorvipath]	SBD	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693648	1.4 ML teriparatide 0.3 MG/ML Pen Injector [Yorvipath]	SBD	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693637	0.56 ML teriparatide 0.3 MG/ML Pen Injector	SCD	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693645	0.98 ML teriparatide 0.3 MG/ML Pen Injector	SCD	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693647	1.4 ML teriparatide 0.3 MG/ML Pen Injector	SCD	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693643	0.56 ML Yorvipath 0.3 MG/ML Pen Injector	SY	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693646	0.98 ML Yorvipath 0.3 MG/ML Pen Injector	SY	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693648	1.4 ML Yorvipath 0.3 MG/ML Pen Injector	SY	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693637	teriparatide 168 MCG (equivalent to palopegteriparatide 1935 MCG) per 0.56 ML Pen Injector	SY	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693645	teriparatide 294 MCG (equivalent to palopegteriparatide 3387 MCG) per 0.98 ML Pen Injector	SY	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693647	teriparatide 420 MCG (equivalent to palopegteriparatide 4838 MCG) per 1.4 ML Pen Injector	SY	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693643	Yorvipath 168 MCG per 0.56 ML Pen Injector	SY	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693646	Yorvipath 294 MCG per 0.98 ML Pen Injector	SY	a1fa23fd-c434-443e-9a17-5750578c8602	7
2693648	Yorvipath 420 MCG per 1.4 ML Pen Injector	SY	a1fa23fd-c434-443e-9a17-5750578c8602	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73362-101-01	73362010101	2 BOX in 1 CARTON (73362-101-01) / 1 SYRINGE in 1 BOX (73362-101-02) / 1 CARTRIDGE in 1 SYRINGE (73362-101-03) / .98 mL in 1 CARTRIDGE	2 box	2024-08-09	No	No	Current
73362-101-02	73362010102	1 in 1 BOX					Historical
73362-101-03	73362010103	0.98 mL in 1 CARTRIDGE	0.98 ml				Historical