PROGESTERONE

Product NDC: 0591-3128
11-digit product format: 005913128
Labeler code: 0591
Product ID: 0591-3128_aacccc63-aa7d-435e-bec5-0aab0e04153f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROGESTERONE
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Actavis Pharma, Inc.
Application: NDA017362
Marketing category: NDA
Marketing start: 1978-05-11
Substance: PROGESTERONE
Active strength: 50 mg/mL
Pharmacologic classes: Progesterone [CS], Progesterone [EPC]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017362-002	PROGESTERONE	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017362-002	PROGESTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017362-002	PROGESTERONE	50MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017362-002	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017362-002	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017362-002	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017362-002	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017362-002	AO	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017362-002	AO	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017362-002	AO	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017362-002	AO	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017362-002	AO	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017362-002	AO	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017362-002	AO	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017362-002	AO	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017362-002	AO	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017362-002	AO	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017362-002	AO	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017362-002	AO	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017362-002	AO	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROGESTERONE	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4G7DS2Q64Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312644	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
a09a3b76-36f1-4d20-930e-7e3da97e7ebd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b46148e2-ee15-98d5-12f0-f5ec8745f6fc	Product name	3	20220927
76820076-f087-4073-b1d1-aa04b361335e	Product name	2	20220921
d3229c1a-4e51-4e04-9b13-00d24fd35242	Product name	1	20200821
213f0591-95c1-b398-40b7-08b31f66b026	Product name	4	20190206
85b2d644-53b2-f2dc-4dbc-859116ce56c0	Product name	1	20140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aac	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-3128-79	PROGESTERONE	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3128-79	ML - Milliliter	0591-3128	3c035d49-2ad7-4cf1-a40d-a46923e44a5a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROGESTERONE	ACTIVE INGREDIENT	4G7DS2Q64Y	PROGESTERONE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.]	17
PROGESTERONE	ACTIVE MOIETY	4G7DS2Q64Y	PROGESTERONE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.]	17
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	PROGESTERONE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.]	17
SESAME OIL	INACTIVE INGREDIENT	QX10HYY4QV	PROGESTERONE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.]	17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-3128	PROGESTERONE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.]	23	Current NDC, Legacy NDC, 1 package rows	20221006_a09a3b76-36f1-4d20-930e-7e3da97e7ebd.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROGESTERONE	PROGESTERONE	Actavis Pharma, Inc.	a09a3b76-36f1-4d20-930e-7e3da97e7ebd	2022-10-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017362 application number: NDA017362 ndc (product): 0591-3128

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4G7DS2Q64Y	PROGESTERONE	57-83-0	PROGESTERONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312644	progesterone 50 MG/ML Injectable Solution	PSN	a09a3b76-36f1-4d20-930e-7e3da97e7ebd	23
312644	progesterone 50 MG/ML Injectable Solution	SCD	a09a3b76-36f1-4d20-930e-7e3da97e7ebd	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-3128-79	00591312879	10 mL in 1 VIAL, MULTI-DOSE (0591-3128-79)	10 ml	1978-05-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROGESTERONE INJECTION USP IN SESAME OIL FOR INTRAMUSCULAR USE ONLY Rx only Revised: September 2014	Actavis Pharma, Inc.	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	23