Oxytocin

Product NDC: 65219-021
11-digit product format: 652190021
Labeler code: 65219
Product ID: 65219-021_9ac3d1b0-5944-4a20-87b1-423a712f429a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXYTOCIN
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: NDA018248
Marketing category: NDA
Marketing start: 2024-05-06
Substance: OXYTOCIN
Active strength: 10 [USP'U]/mL
Pharmacologic classes: Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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	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 1 of 4 · 126 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
2026-08-18 06:07:40	2026-07	N018248-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018248-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018248-003	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018248-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018248-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018248-003	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018248-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018248-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018248-003	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018248-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018248-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018248-003	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018248-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018248-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018248-003	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018248-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018248-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018248-003	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018248-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018248-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018248-003	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018248-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018248-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018248-003	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018248-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018248-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018248-003	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018248-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018248-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018248-003	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018248-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018248-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018248-003	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018248-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018248-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018248-003	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018248-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018248-002	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018248-003	OXYTOCIN	300USP UNITS/30ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD, RS	2007-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018248-001	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2019-12-13 00:20 UTC	2019-12	N018248-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018248-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018248-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018248-002	AP	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Oxytocin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYTOCIN	10 [USP'U]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1JQS135EYN	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1791721	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
4c4c4b69-8bf7-472c-aafe-29805ba5c965	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3124a9ec-4142-06dc-5b1b-5c28cd8ea2fb	Product name	2	20180829
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65219-021-00	Oxytocin	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	1		2
65219-021-01	Oxytocin	25 in 1 TRAY	INJECTION, SOLUTION	25		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65219-021-00	ML - Milliliter	65219-021	e2418f81-f3e2-41af-9491-6f91d8fc5e56	1	2025-10-14
65219-021-01	ML - Milliliter	65219-021	71409996-013d-404a-8a97-f492abf5ebaa	1	2025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65219-021	OXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2	Current NDC, 2 package rows	20250409_4c4c4b69-8bf7-472c-aafe-29805ba5c965.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Oxytocin	OXYTOCIN	REMEDYREPACK INC.	b6f20a2c-3609-4b09-b8f7-8d8eaeb5c242	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018248 application number: NDA018248
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
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 ndc (product): 65219-021
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1JQS135EYN	OXYTOCIN	50-56-6	OXYTOCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1791721	oxytocin 10 UNT in 1 ML Injection	PSN	4c4c4b69-8bf7-472c-aafe-29805ba5c965	2
1791721	1 ML oxytocin 10 UNT/ML Injection	SCD	4c4c4b69-8bf7-472c-aafe-29805ba5c965	2
1791721	oxytocin 10 UNT per 1 ML Injection	SY	4c4c4b69-8bf7-472c-aafe-29805ba5c965	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
65219-021-00	65219002100	1 mL in 1 VIAL, SINGLE-DOSE	1 ml				Historical
65219-021-01	65219002101	25 VIAL, SINGLE-DOSE in 1 TRAY (65219-021-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-021-00)		2024-05-06	No	No	Current