Application 018261

Type: NDA
Sponsor: PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PITOCIN	OXYTOCIN	INJECTABLE;INJECTION	10USP UNITS/ML (10USP UNITS/ML)	Yes	Yes
002	PITOCIN	OXYTOCIN	INJECTABLE;INJECTION	100USP UNITS/10ML (10USP UNITS/ML)	Yes	No
003	PITOCIN	OXYTOCIN	INJECTABLE;INJECTION	500USP UNITS/50ML (10USP UNITS/ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N018261-001	PITOCIN	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N018261-002	PITOCIN	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27
N018261-003	PITOCIN	OXYTOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N018261-001	AP
N018261-002	AP

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 4 of 4 · 132 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
2022-10-28 04:53 UTC	2022-10	N018261-001	PITOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N018261-002	PITOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N018261-003	PITOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018261-001	PITOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N018261-002	PITOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N018261-003	PITOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018261-001	PITOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018261-002	PITOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018261-003	PITOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018261-001	PITOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018261-002	PITOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018261-003	PITOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N018261-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018261-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018261-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018261-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018261-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018261-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018261-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018261-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018261-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018261-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018261-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018261-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018261-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018261-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018261-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018261-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018261-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018261-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018261-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018261-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018261-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018261-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018261-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018261-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018261-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018261-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018261-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018261-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018261-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018261-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018261-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018261-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018261-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018261-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018261-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018261-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018261-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018261-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018261-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018261-002	AP	1	`4b0b4de00fa7…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pitocin	OXYTOCIN	Par Health USA, LLC	6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018261 application number: NDA018261 ndc (product): 42023-130
Pitocin	OXYTOCIN	Par Health USA, LLC	969d5b35-0add-4c23-9605-6a5b6ab65c95	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018261 application number: NDA018261 ndc (product): 42023-116
Pitocin	OXYTOCIN	Par Health USA, LLC	6e5a66fc-e507-497c-b5ce-44a8c95898ad	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018261 application number: NDA018261 ndc (product): 42023-116
Pitocin	OXYTOCIN	Par Health USA, LLC	dddcdcc3-cd4d-4573-98ac-9468bea23a8b	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018261 application number: NDA018261 ndc (product): 42023-116

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42023-116	Pitocin	oxytocin	Par Pharmaceutical, Inc.	NDA	Current
42023-116	Pitocin	oxytocin	Par Pharmaceutical, Inc.	NDA	Current
42023-116	Pitocin	oxytocin	Par Pharmaceutical, Inc.	NDA	Current
42023-116	Pitocin	oxytocin	Par Pharmaceutical, Inc.	NDA	Current
42023-130	Pitocin	oxytocin	Par Pharmaceutical, Inc.	NDA	Current
42023-130	Pitocin	oxytocin	Par Pharmaceutical, Inc.	NDA	Current
42023-130	Pitocin	oxytocin	Par Pharmaceutical, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68286	SUPPL	2021-08-04
67460	SUPPL	2021-05-12
33465	SUPPL	2014-10-03
883	SUPPL	2014-10-03
40790	SUPPL	2008-04-04
20120	SUPPL	2008-04-04
14961	SUPPL	2007-07-31
33464	SUPPL	2007-07-30
14960	SUPPL	2003-03-26
14959	SUPPL	2002-01-10
40789	SUPPL	1997-07-29