Progesterone

Product NDC: 16714-158
11-digit product format: 167140158
Labeler code: 16714
Product ID: 16714-158_b1c812dd-e2c9-b0d0-8ba1-f566ab129797
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Progesterone
Dosage form: CAPSULE
Route: ORAL
Labeler: Northstar Rx LLC
Application: ANDA205229
Marketing category: ANDA
Marketing start: 2021-04-12
Substance: PROGESTERONE
Active strength: 200 mg/1
Pharmacologic classes: Progesterone [CS], Progesterone [EPC]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205229-001	PROGESTERONE	PROGESTERONE	100MG	CAPSULE / ORAL	AB		2017-10-20
A205229-002	PROGESTERONE	PROGESTERONE	200MG	CAPSULE / ORAL	AB		2017-10-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A205229-001	AB
A205229-002	AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205229-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-10-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205229-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-10-20	`bb7c543d1eb4…`

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	A205229-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205229-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205229-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205229-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205229-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205229-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205229-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205229-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205229-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205229-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205229-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205229-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205229-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205229-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205229-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205229-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205229-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205229-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205229-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205229-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205229-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205229-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205229-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205229-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205229-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205229-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205229-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205229-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205229-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205229-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205229-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205229-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205229-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205229-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205229-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205229-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205229-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205229-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205229-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205229-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROGESTERONE	200 mg/1

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
260243	Internal RxNorm lookup
312641	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
73229a76-8de3-4cea-886f-568f0b817fea	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
16714-158-01	Progesterone	100 in 1 BOTTLE	CAPSULE	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-158-01	EA - Each	16714-158	019b6bd8-0306-438e-8e17-7aff724325ee	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-158	PROGESTERONE CAPSULE [NORTHSTAR RX LLC]	2	Current NDC, Legacy NDC, 1 package rows	20240308_73229a76-8de3-4cea-886f-568f0b817fea.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Progesterone	PROGESTERONE	Redpharm Drug	5743b2e4-093f-c59a-e063-6394a90aae2b	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	Bryant Ranch Prepack	1ba10f9d-6e91-4954-ac91-23adcf8805b0	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	Bryant Ranch Prepack	74a7619a-8f74-4889-96f6-5bae478543e8	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	AvKARE	1637ac18-3a37-f3d5-e063-6394a90af157	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	Northstar Rx LLC	73229a76-8de3-4cea-886f-568f0b817fea	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229 ndc (product): 16714-158
Progesterone	PROGESTERONE	Xiromed, LLC	0bf317a8-96d6-849d-7850-9084205a5315	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	Direct_Rx	462ae686-7264-4852-e063-6294a90aae98	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	Preferred Pharmaceuticals Inc.	67842863-209d-4724-9e67-8d0c6282bd1d	2025-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
PROGESTERONE	PROGESTERONE	Direct Rx	dc9e2088-e11e-7d32-e053-2a95a90a2995	2025-01-22	Warnings	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	Proficient Rx LP	80a63b2b-96be-423d-abbd-13acc802f6da	2024-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	A-S Medication Solutions	96c59a1c-d562-46dd-868b-b2decdfef319	2023-11-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	Asclemed USA, Inc.	fd6b9861-04fc-42d8-90c8-021a69fe93e9	2023-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	A-S Medication Solutions	5e0263c5-2cb6-4e02-b883-2c05492a6260	2023-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	Asclemed USA, Inc.	4a741977-1dbb-41e7-a560-9ac02936f8b1	2022-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	Proficient Rx LP	e1546b35-cfa8-4808-9652-db1ba675a4e3	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229
Progesterone	PROGESTERONE	Proficient Rx LP	73e65b35-2266-48a3-98f8-521446a55c22	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205229 application number: ANDA205229

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
260243	progesterone 100 MG Oral Capsule	PSN	73229a76-8de3-4cea-886f-568f0b817fea	3
312641	progesterone 200 MG Oral Capsule	PSN	73229a76-8de3-4cea-886f-568f0b817fea	3
260243	progesterone 100 MG Oral Capsule	SCD	73229a76-8de3-4cea-886f-568f0b817fea	3
312641	progesterone 200 MG Oral Capsule	SCD	73229a76-8de3-4cea-886f-568f0b817fea	3
260243	progesterone 100 MG Oral Capsule	PSN	fd6b9861-04fc-42d8-90c8-021a69fe93e9	2
312641	progesterone 200 MG Oral Capsule	PSN	fd6b9861-04fc-42d8-90c8-021a69fe93e9	2
260243	progesterone 100 MG Oral Capsule	SCD	fd6b9861-04fc-42d8-90c8-021a69fe93e9	2
312641	progesterone 200 MG Oral Capsule	SCD	fd6b9861-04fc-42d8-90c8-021a69fe93e9	2
312641	progesterone 200 MG Oral Capsule	PSN	e3dab203-488d-af9d-e053-2995a90a3043	1
312641	progesterone 200 MG Oral Capsule	SCD	e3dab203-488d-af9d-e053-2995a90a3043	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-158-01	16714015801	100 CAPSULE in 1 BOTTLE (16714-158-01)	100 capsule	2021-04-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Progesterone Capsules	Northstar Rx LLC \| Xiromed Pharma Espana, S.L. \| Laboratorios León Farma, SAU	2026-02-19	HUMAN PRESCRIPTION DRUG LABEL	3
Progesterone Capsules	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-07-06	HUMAN PRESCRIPTION DRUG LABEL	2
Progesterone Capsules	NuCare Pharmaceuticals,Inc.	2022-07-15	HUMAN PRESCRIPTION DRUG LABEL	1