Pitocin

Product NDC: 42023-130
11-digit product format: 420230130
Labeler code: 42023
Product ID: 42023-130_b493de99-bebb-46c3-946c-09c0e9c43832
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxytocin
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Par Health USA, LLC
Application: NDA018261
Marketing category: NDA
Marketing start: 2018-05-01
Substance: OXYTOCIN
Active strength: 10 [iU]/mL
Pharmacologic classes: Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]
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 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
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 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	N018261-001	PITOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018261-002	PITOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018261-003	PITOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018261-001	PITOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018261-002	PITOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018261-003	PITOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018261-001	PITOCIN	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	N018261-002	PITOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018261-003	PITOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018261-001	PITOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018261-002	PITOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018261-003	PITOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018261-001	PITOCIN	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	N018261-002	PITOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018261-003	PITOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018261-001	PITOCIN	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	N018261-002	PITOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018261-003	PITOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018261-001	PITOCIN	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	N018261-002	PITOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018261-003	PITOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018261-001	PITOCIN	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	N018261-002	PITOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018261-003	PITOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018261-001	PITOCIN	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	N018261-002	PITOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018261-003	PITOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018261-001	PITOCIN	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	N018261-002	PITOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018261-003	PITOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018261-001	PITOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018261-002	PITOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018261-003	PITOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018261-001	PITOCIN	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	N018261-002	PITOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018261-003	PITOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018261-001	PITOCIN	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	N018261-002	PITOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE / INJECTION	AP	RLD	2007-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018261-003	PITOCIN	500USP UNITS/50ML (10USP UNITS/ML)	INJECTABLE / INJECTION		RLD	2012-09-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018261-001	PITOCIN	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	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…`
2019-12-13 00:20 UTC	2019-12	N018261-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018261-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018261-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018261-002	AP	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pitocin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYTOCIN	10 [iU]/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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
207315	Internal RxNorm lookup
238013	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
6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1	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
42023-130-06	Pitocin	50 mL in 1 VIAL	INJECTION	50		15
42023-130-06	Pitocin	6 in 1 CARTON	INJECTION	6		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42023-130-06	ML - Milliliter	42023-130	56c61cbd-ef1f-452b-8211-8a6884e8195b	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
oxytocin	ACTIVE INGREDIENT	1JQS135EYN	PITOCIN (OXYTOCIN) INJECTION [JHP PHARMACEUTICALS LLC]	4
oxytocin	ACTIVE MOIETY	1JQS135EYN	PITOCIN (OXYTOCIN) INJECTION [JHP PHARMACEUTICALS LLC]	4
acetic acid	INACTIVE INGREDIENT	Q40Q9N063P	PITOCIN (OXYTOCIN) INJECTION [JHP PHARMACEUTICALS LLC]	4
chlorobutanol	INACTIVE INGREDIENT	HM4YQM8WRC	PITOCIN (OXYTOCIN) INJECTION [JHP PHARMACEUTICALS LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42023-130	PITOCIN (OXYTOCIN) INJECTION [ENDO USA, INC.]	12	Current NDC, Legacy NDC, 2 package rows	20240913_6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1.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 · 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
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
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

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
238013	oxytocin 10 UNT/ML Injectable Solution	PSN	6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1	15
207315	Pitocin 10 UNT/ML Injectable Solution	PSN	6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1	15
207315	oxytocin 10 UNT/ML Injectable Solution [Pitocin]	SBD	6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1	15
238013	oxytocin 10 UNT/ML Injectable Solution	SCD	6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1	15
207315	Pitocin 10 UNT/ML Injectable Solution	SY	6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42023-130-06	42023013006	6 VIAL in 1 CARTON (42023-130-06) / 50 mL in 1 VIAL	6 vial	2018-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pitocin ® (Oxytocin Injection, USP) Synthetic	Par Health USA, LLC	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	15