Pitocin

Product NDC: 42023-116
Requested package NDC: 42023-116-01
11-digit product format: 420230116
Labeler code: 42023
Product ID: 42023-116_c269323e-4670-4bb5-b67b-f3e0e7a225c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxytocin
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Par Health USA, LLC
Application: NDA018261
Marketing category: NDA
Marketing start: 2024-05-06
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	42023-116	42023-116-01	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
207315	Internal RxNorm lookup
238013	Internal RxNorm lookup
1791721	Internal RxNorm lookup
1791723	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
6e5a66fc-e507-497c-b5ce-44a8c95898ad	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	SPL version
42023-116-01	Pitocin	10 mL in 1 VIAL	INJECTION	10	16
42023-116-01	Pitocin	1 in 1 CARTON	INJECTION	1	16
42023-116-02	Pitocin	25 in 1 CARTON	INJECTION	25	16
42023-116-02	Pitocin	10 mL in 1 VIAL	INJECTION	10	16
42023-116-25	Pitocin	1 mL in 1 VIAL	INJECTION	1	16
42023-116-25	Pitocin	25 in 1 TRAY	INJECTION	25	16
42023-116-93	Pitocin	10 mL in 1 VIAL	INJECTION	10	15
42023-116-93	Pitocin	25 in 1 CARTON	INJECTION	25	15
42023-116-73	Pitocin	25 in 1 CARTON	INJECTION	25	10
42023-116-73	Pitocin	10 mL in 1 VIAL	INJECTION	10	10
42023-116-83	Pitocin	25 in 1 CARTON	INJECTION	25	10
42023-116-83	Pitocin	1 mL in 1 VIAL	INJECTION	1	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42023-116-01	ML - Milliliter	42023-116	410c7534-e462-44d9-8905-79ea5731cbcb	1	2012-07-24
42023-116-02	ML - Milliliter	42023-116	3cef2e57-13fa-4492-b875-255bdfc8b43c	1	2012-07-24
42023-116-25	ML - Milliliter	42023-116	d9a9284b-977e-4d59-9d55-56800570cf68	1	2012-07-24
42023-116-73	ML - Milliliter	42023-116	260aafe1-5f7a-4444-8686-0064b0e83d50	1	2024-02-14
42023-116-83	ML - Milliliter	42023-116	7ca7d97f-dbb6-4b5d-94cc-f0d695360653	1	2024-01-04
42023-116-93	ML - Milliliter	42023-116	1b6411dd-863d-4be4-a039-a682dad15745	1	2024-07-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
oxytocin	ACTIVE INGREDIENT	1JQS135EYN	PITOCIN (OXYTOCIN) INJECTION [PAR PHARMACEUTICAL, INC.]	6
oxytocin	ACTIVE MOIETY	1JQS135EYN	PITOCIN (OXYTOCIN) INJECTION [PAR PHARMACEUTICAL, INC.]	6
acetic acid	INACTIVE INGREDIENT	Q40Q9N063P	PITOCIN (OXYTOCIN) INJECTION [PAR PHARMACEUTICAL, INC.]	6
chlorobutanol	INACTIVE INGREDIENT	HM4YQM8WRC	PITOCIN (OXYTOCIN) INJECTION [PAR PHARMACEUTICAL, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42023-116	PITOCIN (OXYTOCIN) INJECTION [ENDO USA, INC.]	14	Current NDC, Legacy NDC, 6 package rows	20240913_969d5b35-0add-4c23-9605-6a5b6ab65c95.zip
42023-116	PITOCIN (OXYTOCIN) INJECTION [ENDO USA, INC.]	13	Current NDC, Legacy NDC, 2 package rows	20240913_6e5a66fc-e507-497c-b5ce-44a8c95898ad.zip
42023-116	PITOCIN (OXYTOCIN) INJECTION [ENDO USA, INC.]	9	Current NDC, Legacy NDC, 4 package rows	20240913_dddcdcc3-cd4d-4573-98ac-9468bea23a8b.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
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 (package): 42023-116-01 ndc (product): 42023-116 ndc11 (package): 42023011601
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

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	969d5b35-0add-4c23-9605-6a5b6ab65c95	16
238013	oxytocin 10 UNT/ML Injectable Solution	PSN	969d5b35-0add-4c23-9605-6a5b6ab65c95	16
1791723	Pitocin 10 UNT in 1 ML Injection	PSN	969d5b35-0add-4c23-9605-6a5b6ab65c95	16
207315	Pitocin 10 UNT/ML Injectable Solution	PSN	969d5b35-0add-4c23-9605-6a5b6ab65c95	16
1791723	1 ML oxytocin 10 UNT/ML Injection [Pitocin]	SBD	969d5b35-0add-4c23-9605-6a5b6ab65c95	16
207315	oxytocin 10 UNT/ML Injectable Solution [Pitocin]	SBD	969d5b35-0add-4c23-9605-6a5b6ab65c95	16
1791721	1 ML oxytocin 10 UNT/ML Injection	SCD	969d5b35-0add-4c23-9605-6a5b6ab65c95	16
238013	oxytocin 10 UNT/ML Injectable Solution	SCD	969d5b35-0add-4c23-9605-6a5b6ab65c95	16
1791721	oxytocin 10 UNT per 1 ML Injection	SY	969d5b35-0add-4c23-9605-6a5b6ab65c95	16
1791723	Pitocin 10 UNT per 1 ML Injection	SY	969d5b35-0add-4c23-9605-6a5b6ab65c95	16
207315	Pitocin 10 UNT/ML Injectable Solution	SY	969d5b35-0add-4c23-9605-6a5b6ab65c95	16
1791721	oxytocin 10 UNT in 1 ML Injection	PSN	6e5a66fc-e507-497c-b5ce-44a8c95898ad	15
238013	oxytocin 10 UNT/ML Injectable Solution	PSN	6e5a66fc-e507-497c-b5ce-44a8c95898ad	15
1791723	Pitocin 10 UNT in 1 ML Injection	PSN	6e5a66fc-e507-497c-b5ce-44a8c95898ad	15
207315	Pitocin 10 UNT/ML Injectable Solution	PSN	6e5a66fc-e507-497c-b5ce-44a8c95898ad	15
1791723	1 ML oxytocin 10 UNT/ML Injection [Pitocin]	SBD	6e5a66fc-e507-497c-b5ce-44a8c95898ad	15
207315	oxytocin 10 UNT/ML Injectable Solution [Pitocin]	SBD	6e5a66fc-e507-497c-b5ce-44a8c95898ad	15
1791721	1 ML oxytocin 10 UNT/ML Injection	SCD	6e5a66fc-e507-497c-b5ce-44a8c95898ad	15
238013	oxytocin 10 UNT/ML Injectable Solution	SCD	6e5a66fc-e507-497c-b5ce-44a8c95898ad	15
1791721	oxytocin 10 UNT per 1 ML Injection	SY	6e5a66fc-e507-497c-b5ce-44a8c95898ad	15
1791723	Pitocin 10 UNT per 1 ML Injection	SY	6e5a66fc-e507-497c-b5ce-44a8c95898ad	15
207315	Pitocin 10 UNT/ML Injectable Solution	SY	6e5a66fc-e507-497c-b5ce-44a8c95898ad	15
1791721	oxytocin 10 UNT in 1 ML Injection	PSN	dddcdcc3-cd4d-4573-98ac-9468bea23a8b	10
238013	oxytocin 10 UNT/ML Injectable Solution	PSN	dddcdcc3-cd4d-4573-98ac-9468bea23a8b	10
1791723	Pitocin 10 UNT in 1 ML Injection	PSN	dddcdcc3-cd4d-4573-98ac-9468bea23a8b	10
207315	Pitocin 10 UNT/ML Injectable Solution	PSN	dddcdcc3-cd4d-4573-98ac-9468bea23a8b	10
1791723	1 ML oxytocin 10 UNT/ML Injection [Pitocin]	SBD	dddcdcc3-cd4d-4573-98ac-9468bea23a8b	10
207315	oxytocin 10 UNT/ML Injectable Solution [Pitocin]	SBD	dddcdcc3-cd4d-4573-98ac-9468bea23a8b	10
1791721	1 ML oxytocin 10 UNT/ML Injection	SCD	dddcdcc3-cd4d-4573-98ac-9468bea23a8b	10
238013	oxytocin 10 UNT/ML Injectable Solution	SCD	dddcdcc3-cd4d-4573-98ac-9468bea23a8b	10
1791721	oxytocin 10 UNT per 1 ML Injection	SY	dddcdcc3-cd4d-4573-98ac-9468bea23a8b	10
1791723	Pitocin 10 UNT per 1 ML Injection	SY	dddcdcc3-cd4d-4573-98ac-9468bea23a8b	10
207315	Pitocin 10 UNT/ML Injectable Solution	SY	dddcdcc3-cd4d-4573-98ac-9468bea23a8b	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42023-116-01	42023011601	1 VIAL in 1 CARTON (42023-116-01) > 10 mL in 1 VIAL	1 vial	2008-02-01	2021-08-31	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	16
Pitocin ® (Oxytocin Injection, USP) Synthetic	Par Health USA, LLC \| Endo USA, Inc.	2026-05-05	HUMAN PRESCRIPTION DRUG LABEL	15
Pitocin ® (Oxytocin Injection, USP) Synthetic	Par Health USA, LLC \| Endo USA, Inc.	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL	10
Model AA-8565CV-ACT Model AA-8565CV	Aerospace Accessory Service, Inc	2021-05-18	MEDICAL DEVICE	3