Progesterone

Product NDC: 43598-350
Requested package NDC: 43598-350-69
11-digit product format: 435980350
Labeler code: 43598
Product ID: 43598-350_4b8f3d16-f096-32f0-65f9-230ab8c292b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Progesterone
Dosage form: CAPSULE
Route: ORAL
Labeler: Dr. Reddy�s Laboratories, Inc.
Application: ANDA208801
Marketing category: ANDA
Marketing start: 2017-03-25
Substance: PROGESTERONE
Active strength: 200 mg/1
Pharmacologic classes: Progesterone [CS], Progesterone [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
unfinished package	package	43598-350	43598-350-69	UNFINISHED	Active or certified unfinished drug listing		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 · 19 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A208801-001	PROGESTERONE	PROGESTERONE	100MG	CAPSULE / ORAL	AB		2017-02-28
A208801-002	PROGESTERONE	PROGESTERONE	200MG	CAPSULE / ORAL	AB		2017-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208801-001	AB
A208801-002	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	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208801-001	PROGESTERONE	100MG	CAPSULE / ORAL	AB	2017-02-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208801-002	PROGESTERONE	200MG	CAPSULE / ORAL	AB	2017-02-28	`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	A208801-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208801-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208801-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208801-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208801-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208801-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208801-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208801-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208801-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208801-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208801-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208801-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208801-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208801-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208801-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208801-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208801-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208801-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208801-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208801-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208801-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208801-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208801-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208801-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208801-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208801-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208801-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208801-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208801-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208801-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208801-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208801-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208801-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208801-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208801-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208801-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208801-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208801-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208801-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208801-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

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
efded380-02ff-68c9-13e4-47a561ede440	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43598-350-69	2020-01-31	C162847	48780-1	9d75b9d0-8c77-f424-e053-dadaa90a57ce	3788659e-f4ee-7d4f-2ae1-947df971d7bf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43598-350-01	Progesterone	100 in 1 BOTTLE	CAPSULE	100		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-350-01	EA - Each	43598-350	c0865278-0820-4a10-83e7-b7390c4c8ef1	1	2017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-350	PROGESTERONE CAPSULE [DR. REDDY&RSQUO;S LABORATORIES, INC.]	8	Current NDC, Legacy NDC, 1 package rows	20240316_efded380-02ff-68c9-13e4-47a561ede440.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	Dr. Reddys Laboratories, Inc.	efded380-02ff-68c9-13e4-47a561ede440	2024-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208801 application number: ANDA208801 ndc (product): 43598-350

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	efded380-02ff-68c9-13e4-47a561ede440	8
312641	progesterone 200 MG Oral Capsule	PSN	efded380-02ff-68c9-13e4-47a561ede440	8
260243	progesterone 100 MG Oral Capsule	SCD	efded380-02ff-68c9-13e4-47a561ede440	8
312641	progesterone 200 MG Oral Capsule	SCD	efded380-02ff-68c9-13e4-47a561ede440	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
43598-350-69	43598035069	12000 CAPSULE in 1 POUCH (43598-350-69)	12000 capsule	25-MAR-17	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Progesterone Capsules, 100 mg and 200 mg	Dr. Reddy’s Laboratories, Inc.	2024-03-05	HUMAN PRESCRIPTION DRUG LABEL	8
Progesterone Capsules, 100 mg and 200 mg	Golden State Medical Supply, Inc.	2019-12-11	HUMAN PRESCRIPTION DRUG LABEL	3