Progesterone

Product NDC: 65162-807
11-digit product format: 651620807
Labeler code: 65162
Product ID: 65162-807_6f7c3e58-3b68-4d6f-8502-74a41478d1c4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Progesterone
Dosage form: CAPSULE
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA207724
Marketing category: ANDA
Marketing start: 2017-09-11
Substance: PROGESTERONE
Active strength: 100 mg/1
Pharmacologic classes: Progesterone [CS], Progesterone [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROGESTERONE	100 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	4G7DS2Q64Y
Rxcui	260243, 312641

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
65162-807-10	Progesterone	100 in 1 BOTTLE	CAPSULE	100		13
65162-807-50	Progesterone	500 in 1 BOTTLE	CAPSULE	500		13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-807	PROGESTERONE CAPSULE [AMNEAL PHARMACEUTICALS LLC]	12	Current NDC, Legacy NDC, 2 package rows	20240425_4de0715d-a3b9-42fa-b4e4-6371151fd75c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
260243	progesterone 100 MG Oral Capsule	PSN	4de0715d-a3b9-42fa-b4e4-6371151fd75c	13
312641	progesterone 200 MG Oral Capsule	PSN	4de0715d-a3b9-42fa-b4e4-6371151fd75c	13
260243	progesterone 100 MG Oral Capsule	SCD	4de0715d-a3b9-42fa-b4e4-6371151fd75c	13
312641	progesterone 200 MG Oral Capsule	SCD	4de0715d-a3b9-42fa-b4e4-6371151fd75c	13
260243	progesterone 100 MG Oral Capsule	PSN	f26af2f3-4d1c-408f-8aa0-adbd1729d965	3
260243	progesterone 100 MG Oral Capsule	SCD	f26af2f3-4d1c-408f-8aa0-adbd1729d965	3
260243	progesterone 100 MG Oral Capsule	PSN	19716042-8025-43a3-b26d-e0fd7d2587eb	2
312641	progesterone 200 MG Oral Capsule	PSN	19716042-8025-43a3-b26d-e0fd7d2587eb	2
260243	progesterone 100 MG Oral Capsule	SCD	19716042-8025-43a3-b26d-e0fd7d2587eb	2
312641	progesterone 200 MG Oral Capsule	SCD	19716042-8025-43a3-b26d-e0fd7d2587eb	2
260243	progesterone 100 MG Oral Capsule	PSN	d7619751-47b4-47c9-b716-e2a704b350c8	1
260243	progesterone 100 MG Oral Capsule	SCD	d7619751-47b4-47c9-b716-e2a704b350c8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-807-10	65162080710	100 CAPSULE in 1 BOTTLE (65162-807-10)	100 capsule	2017-09-11	0000-00-00	No	No	Current
65162-807-50	65162080750	500 CAPSULE in 1 BOTTLE (65162-807-50)	500 capsule	2017-09-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Progesterone Capsules (progesterone, USP), 100 mg and 200 mg Rx only	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals of New York, LLC	2026-02-24	HUMAN PRESCRIPTION DRUG LABEL	13
Progesterone Capsules (progesterone, USP), 100 mg and 200 mg Rx only	REMEDYREPACK INC.	2026-01-21	HUMAN PRESCRIPTION DRUG LABEL	1
Progesterone Capsules (progesterone, USP), 100 mg and 200 mg	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-10-12	HUMAN PRESCRIPTION DRUG LABEL	2
Progesterone Capsules (progesterone, USP), 100 mg and 200 mg	A-S Medication Solutions	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	3