Application 018248

Type: NDA
Sponsor: FRESENIUS KABI USA

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
003	OXYTOCIN	OXYTOCIN	INJECTABLE;INJECTION	300USP UNITS/30ML (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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018248-001	OXYTOCIN	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N018248-002	OXYTOCIN	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N018248-003	OXYTOCIN	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018248-001	AP
N018248-002	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	N018248-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N018248-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N018248-003	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018248-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N018248-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N018248-003	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018248-001	OXYTOCIN	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	N018248-002	OXYTOCIN	100USP UNITS/10ML (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	N018248-003	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018248-001	OXYTOCIN	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	N018248-002	OXYTOCIN	100USP UNITS/10ML (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	N018248-003	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27	`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	N018248-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018248-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018248-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018248-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018248-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018248-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018248-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018248-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018248-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018248-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018248-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018248-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018248-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018248-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018248-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018248-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018248-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018248-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018248-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018248-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018248-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018248-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018248-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018248-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018248-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018248-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018248-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018248-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018248-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018248-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018248-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018248-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018248-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018248-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018248-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018248-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018248-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018248-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018248-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018248-002	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 · 5 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	Exact identifier application applno (NDA): 018248 application number: NDA018248
Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	c7fd585a-99b7-4309-b003-a6cbef05372c	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018248 application number: NDA018248 ndc (product): 63323-012
Oxytocin	OXYTOCIN	Cardinal Health 107, LLC	18fe8365-86e3-414e-84dc-c98e097a2f36	2025-06-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018248 application number: NDA018248 ndc (product): 55154-9584
Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	4c4c4b69-8bf7-472c-aafe-29805ba5c965	2025-03-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018248 application number: NDA018248
Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	6d7d1280-f286-4f39-89f3-2b96571810e6	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018248 application number: NDA018248 ndc (product): 63323-012

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55154-9356	Oxytocin	OXYTOCIN	Cardinal Health	NDA	Current
55154-9577	Oxytocin	OXYTOCIN	Cardinal Health	NDA	Current
55154-9577	Oxytocin	OXYTOCIN	Cardinal Health	NDA	Current
55154-9584	Oxytocin	OXYTOCIN	Cardinal Health	NDA	Current
55154-9584	Oxytocin	OXYTOCIN	Cardinal Health 107, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	APP Pharmaceuticals, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72125	SUPPL	2022-09-21
72123	SUPPL	2022-09-21
14958	SUPPL	2007-07-30
20119	SUPPL	2007-07-09
20118	SUPPL	2007-07-09