PYLARIFY

Product NDC: 71258-022
11-digit product format: 712580022
Labeler code: 71258
Product ID: 71258-022_db2acb00-3e3b-4ecc-b532-08e456075404
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PIFLUFOLASTAT F-18
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Progenics Pharmaceuticals, Inc.
Application: NDA214793
Marketing category: NDA
Marketing start: 2021-05-26
Substance: PIFLUFOLASTAT F-18
Active strength: 80 mCi/mL
Pharmacologic classes: Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [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
N214793-001	PYLARIFY	PIFLUFOLASTAT F-18	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-05-26

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	Submission date
N214793-001	8487129	2027-11-07		Drug substance, Drug product	2021-06-21
N214793-001	12070513	2029-07-31	U-3130	Drug substance, Drug product	2024-12-20
N214793-001	9861713	2029-07-31	U-3130	Drug substance, Drug product	2021-06-21
N214793-001	8778305	2030-09-21	U-3130	Drug substance, Drug product	2021-06-21
N214793-001	10947197	2037-06-09	U-3130	Drug substance, Drug product	2021-06-21
N214793-001	11851407	2037-06-09	U-3130	Drug substance, Drug product	2024-01-17

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214793-001	NCE	2026-05-26

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
2026-09-14 22:38:34	2026-08	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214793-001	PYLARIFY	50ML (1-80mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-05-26	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N214793-001	8487129	2027-11-07		Drug substance, Drug product	2021-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214793-001	12070513	2029-07-31	U-3130	Drug substance, Drug product	2024-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214793-001	9861713	2029-07-31	U-3130	Drug substance, Drug product	2021-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214793-001	8778305	2030-09-21	U-3130	Drug substance, Drug product	2021-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214793-001	10947197	2037-06-09	U-3130	Drug substance, Drug product	2021-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214793-001	11851407	2037-06-09	U-3130	Drug substance, Drug product	2024-01-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214793-001	8487129	2027-11-07		Drug substance, Drug product	2021-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214793-001	12070513	2029-07-31	U-3130	Drug substance, Drug product	2024-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214793-001	9861713	2029-07-31	U-3130	Drug substance, Drug product	2021-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214793-001	8778305	2030-09-21	U-3130	Drug substance, Drug product	2021-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214793-001	10947197	2037-06-09	U-3130	Drug substance, Drug product	2021-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214793-001	11851407	2037-06-09	U-3130	Drug substance, Drug product	2024-01-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214793-001	8487129	2027-11-07		Drug substance, Drug product	2021-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214793-001	12070513	2029-07-31	U-3130	Drug substance, Drug product	2024-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214793-001	9861713	2029-07-31	U-3130	Drug substance, Drug product	2021-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214793-001	8778305	2030-09-21	U-3130	Drug substance, Drug product	2021-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214793-001	10947197	2037-06-09	U-3130	Drug substance, Drug product	2021-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214793-001	11851407	2037-06-09	U-3130	Drug substance, Drug product	2024-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214793-001	8487129	2027-11-07		Drug substance, Drug product	2021-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214793-001	12070513	2029-07-31	U-3130	Drug substance, Drug product	2024-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214793-001	9861713	2029-07-31	U-3130	Drug substance, Drug product	2021-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214793-001	8778305	2030-09-21	U-3130	Drug substance, Drug product	2021-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214793-001	10947197	2037-06-09	U-3130	Drug substance, Drug product	2021-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214793-001	11851407	2037-06-09	U-3130	Drug substance, Drug product	2024-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214793-001	8487129	2027-11-07		Drug substance, Drug product	2021-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214793-001	12070513	2029-07-31	U-3130	Drug substance, Drug product	2024-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214793-001	9861713	2029-07-31	U-3130	Drug substance, Drug product	2021-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214793-001	8778305	2030-09-21	U-3130	Drug substance, Drug product	2021-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214793-001	10947197	2037-06-09	U-3130	Drug substance, Drug product	2021-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214793-001	11851407	2037-06-09	U-3130	Drug substance, Drug product	2024-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214793-001	8487129	2027-11-07		Drug substance, Drug product	2021-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214793-001	12070513	2029-07-31	U-3130	Drug substance, Drug product	2024-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214793-001	9861713	2029-07-31	U-3130	Drug substance, Drug product	2021-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214793-001	8778305	2030-09-21	U-3130	Drug substance, Drug product	2021-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214793-001	10947197	2037-06-09	U-3130	Drug substance, Drug product	2021-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214793-001	11851407	2037-06-09	U-3130	Drug substance, Drug product	2024-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214793-001	8487129	2027-11-07		Drug substance, Drug product	2021-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214793-001	12070513	2029-07-31	U-3130	Drug substance, Drug product	2024-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214793-001	9861713	2029-07-31	U-3130	Drug substance, Drug product	2021-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214793-001	8778305	2030-09-21	U-3130	Drug substance, Drug product	2021-06-21	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N214793-001	NCE	2026-05-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214793-001	NCE	2026-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214793-001	NCE	2026-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214793-001	NCE	2026-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214793-001	NCE	2026-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214793-001	NCE	2026-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214793-001	NCE	2026-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214793-001	NCE	2026-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214793-001	NCE	2026-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214793-001	NCE	2026-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214793-001	NCE	2026-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214793-001	NCE	2026-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214793-001	NCE	2026-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214793-001	NCE	2026-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214793-001	NCE	2026-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214793-001	NCE	2026-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214793-001	NCE	2026-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214793-001	NCE	2026-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214793-001	NCE	2026-05-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214793-001	NCE	2026-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214793-001	NCE	2026-05-26	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214793-001	NCE	2026-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214793-001	NCE	2026-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214793-001	NCE	2026-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214793-001	NCE	2026-05-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214793-001	NCE	2026-05-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214793-001	NCE	2026-05-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214793-001	NCE	2026-05-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214793-001	NCE	2026-05-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214793-001	NCE	2026-05-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214793-001	NCE	2026-05-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214793-001	NCE	2026-05-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214793-001	NCE	2026-05-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214793-001	NCE	2026-05-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214793-001	NCE	2026-05-26	`a50c72e98297…`

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: PYLARIFY
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PIFLUFOLASTAT F-18	80 mCi/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3934EF02T7	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
a00e5cbc-4fd5-4280-82ec-cd3498df4553	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8970a68b-73c2-49f3-9ddb-686a3e1f7cbb	Product name	1	20211216

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71258-022-01	PYLARIFY	50 mL in 1 VIAL, MULTI-DOSE	INJECTION	50		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71258-022-00	EA - Each	71258-022	89374439-ea38-4d31-bafa-5d8c9264a3c8	1	2022-01-06
71258-022-01	EA - Each	71258-022	8fbc2685-5332-4d06-80bb-f937365cf060	1	2025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71258-022	PYLARIFY (PIFLUFOLASTAT F-18) INJECTION [PROGENICS PHARMACEUTICALS, INC.]	10	Current NDC, Legacy NDC, 1 package rows	20250308_a00e5cbc-4fd5-4280-82ec-cd3498df4553.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
PYLARIFY	PIFLUFOLASTAT F-18	Progenics Pharmaceuticals, Inc.	a00e5cbc-4fd5-4280-82ec-cd3498df4553	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214793 application number: NDA214793 ndc (product): 71258-022

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71258-022-00	71258002200	5 mL in 1 SYRINGE (71258-022-00)	5 ml	2021-05-26	0000-00-00	No	No	Current
71258-022-01	71258002201	50 mL in 1 VIAL, MULTI-DOSE (71258-022-01)	50 ml	2021-05-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ISOTONIC SODIUM CHLORIDE SOLUTION	Progenics Pharmaceuticals, Inc. \| Asymchem Life Science (Tianjin) Co., Ltd. \| PETNET SOLUTIONS, INC. \| SOFIE Co. dba SOFIE \| N-Molecular Inc. dba SOFIE \| N-Molecular, Inc. dba SOFIE \| Precision Nuclear, LLC \| PharmaLogic Colorado, LLC \| The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute \| Hot Shots Nuclear Medicine, LLC dba Midwest Positron Technology, LLC \| Essential Isotopes, LLC \| PETNET Solutions Inc. \| Wisconsin Medical Radiopharmacy, LLC \| Pharmalogic Puerto Rico, Inc. \| P.E.T.NET Houston, LLC \| Pharmalogic New York City LLC \| Pharmalogic Holdings Corp. \| Pharmalogic Los Angeles, LLC \| Pharmalogic Salt Lake City, LLC \| Pharmalogic Austin, LLC \| Jubilant DraxImage Inc., dba Jubilant Radiopharma \| UIHC-PET Imaging Center \| Pharmalogic Georgia, LLC \| Precision Nuclear of Virginia, LLC \| BAMF Health, Inc. \| Pharmalogic South Carolina, LLC	2026-02-18	HUMAN PRESCRIPTION DRUG LABEL	11