Application 018243

Type: NDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYTOCIN	OXYTOCIN	INJECTABLE;INJECTION	10USP UNITS/ML (10USP UNITS/ML)	Yes	Yes
002	OXYTOCIN	OXYTOCIN	INJECTABLE;INJECTION	100USP UNITS/10ML (10USP UNITS/ML)	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018243-001	OXYTOCIN	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N018243-002	OXYTOCIN	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018243-001	AP
N018243-002	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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018243-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018243-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2007-01-10	`3a93d1ddd44b…`

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	N018243-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018243-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018243-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018243-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018243-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018243-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018243-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018243-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018243-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018243-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018243-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018243-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018243-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018243-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018243-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018243-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018243-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018243-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018243-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018243-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018243-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018243-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018243-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018243-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018243-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018243-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018243-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018243-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018243-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018243-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018243-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018243-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018243-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018243-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018243-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018243-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018243-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018243-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018243-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018243-002	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxytocin	OXYTOCIN	REMEDYREPACK INC.	b6f20a2c-3609-4b09-b8f7-8d8eaeb5c242	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: Oxytocin generic name: OXYTOCIN
Pitocin	OXYTOCIN	Par Health USA, LLC	6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYTOCIN
Pitocin	OXYTOCIN	Par Health USA, LLC	969d5b35-0add-4c23-9605-6a5b6ab65c95	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYTOCIN
Pitocin	OXYTOCIN	Par Health USA, LLC	6e5a66fc-e507-497c-b5ce-44a8c95898ad	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYTOCIN
Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	c7fd585a-99b7-4309-b003-a6cbef05372c	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: Oxytocin generic name: OXYTOCIN
Oxytocin	OXYTOCIN	Cardinal Health 107, LLC	18fe8365-86e3-414e-84dc-c98e097a2f36	2025-06-20	Warnings, Adverse reactions	Name fallback brand name: Oxytocin generic name: OXYTOCIN
Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	4c4c4b69-8bf7-472c-aafe-29805ba5c965	2025-03-24	Warnings, Adverse reactions	Name fallback brand name: Oxytocin generic name: OXYTOCIN
Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	6d7d1280-f286-4f39-89f3-2b96571810e6	2024-10-15	Warnings, Adverse reactions	Name fallback brand name: Oxytocin generic name: OXYTOCIN
Pitocin	OXYTOCIN	Par Health USA, LLC	dddcdcc3-cd4d-4573-98ac-9468bea23a8b	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYTOCIN
Oxytocin	OXYTOCIN	West-Ward Pharmaceuticals Corp	d16a48c5-6b71-40a0-bcda-204f043fe832	2018-12-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxytocin generic name: OXYTOCIN

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-6114	Oxytocin	Oxytocin	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6114	Oxytocin	Oxytocin	West-Ward Pharmaceutical Corp.	NDA	Current
0641-6115	Oxytocin	Oxytocin	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6115	Oxytocin	Oxytocin	West-Ward Pharmaceutical Corp.	NDA	Current