Provera

Product NDC: 0009-0065
11-digit product format: 000090065
Labeler code: 0009
Product ID: 0009-0065_80c81ad8-3d42-4a21-ac4c-d331bc5e4956
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: medroxyprogesterone acetate
Dosage form: TABLET
Route: ORAL
Labeler: Pharmacia & Upjohn Company LLC
Application: NDA011839
Marketing category: NDA
Marketing start: 2019-09-03
Substance: MEDROXYPROGESTERONE ACETATE
Active strength: 2.5 mg/1
Pharmacologic classes: Progesterone Congeners [CS], Progestin [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 1.

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
N011839-001	PROVERA	MEDROXYPROGESTERONE ACETATE	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982
N011839-003	PROVERA	MEDROXYPROGESTERONE ACETATE	5MG	TABLET / ORAL	AB	RLD, Approved before 1982
N011839-004	PROVERA	MEDROXYPROGESTERONE ACETATE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N011839-001	AB
N011839-003	AB
N011839-004	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011839-003	PROVERA	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011839-004	PROVERA	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011839-001	PROVERA	2.5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011839-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011839-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011839-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011839-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011839-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011839-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011839-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011839-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011839-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011839-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011839-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011839-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011839-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011839-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011839-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011839-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011839-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011839-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011839-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011839-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011839-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011839-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011839-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011839-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011839-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011839-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011839-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011839-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011839-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011839-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011839-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011839-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011839-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011839-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011839-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011839-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011839-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011839-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011839-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011839-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEDROXYPROGESTERONE ACETATE	2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C2QI4IOI2G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000114	Internal RxNorm lookup
1000124	Internal RxNorm lookup
1000135	Internal RxNorm lookup
1000139	Internal RxNorm lookup
1000141	Internal RxNorm lookup
1000145	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
a586be28-96af-4fed-a13f-9b94fd4c7405	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dce	Product name	6	20240606
882e78d5-69f7-4a43-812f-1c1628241bbc	Product name	1	20150910
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2	Product name	1	20140508
51a98800-9a04-9e42-2219-e588f17f9e48	Product name	1	20140508
f363ed61-d8ad-8f59-ee92-52a12578e008	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0009-0065-01	Provera	100 in 1 BOTTLE	TABLET	100		26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0009-0065-01	EA - Each	0009-0065	5d0d874b-1da1-4dca-90b1-7424cdf48ad7	1	2019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MEDROXYPROGESTERONE ACETATE	ACTIVE INGREDIENT	C2QI4IOI2G	PROVERA (MEDROXYPROGESTERONE ACETATE) TABLET [PHARMACIA AND UPJOHN COMPANY]	12
MEDROXYPROGESTERONE	ACTIVE MOIETY	HSU1C9YRES	PROVERA (MEDROXYPROGESTERONE ACETATE) TABLET [PHARMACIA AND UPJOHN COMPANY]	12
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	PROVERA (MEDROXYPROGESTERONE ACETATE) TABLET [PHARMACIA AND UPJOHN COMPANY]	12
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROVERA (MEDROXYPROGESTERONE ACETATE) TABLET [PHARMACIA AND UPJOHN COMPANY]	12
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PROVERA (MEDROXYPROGESTERONE ACETATE) TABLET [PHARMACIA AND UPJOHN COMPANY]	12
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	PROVERA (MEDROXYPROGESTERONE ACETATE) TABLET [PHARMACIA AND UPJOHN COMPANY]	12
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	PROVERA (MEDROXYPROGESTERONE ACETATE) TABLET [PHARMACIA AND UPJOHN COMPANY]	12
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PROVERA (MEDROXYPROGESTERONE ACETATE) TABLET [PHARMACIA AND UPJOHN COMPANY]	12
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PROVERA (MEDROXYPROGESTERONE ACETATE) TABLET [PHARMACIA AND UPJOHN COMPANY]	12
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PROVERA (MEDROXYPROGESTERONE ACETATE) TABLET [PHARMACIA AND UPJOHN COMPANY]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0009-0065	PROVERA (MEDROXYPROGESTERONE ACETATE) TABLET [PHARMACIA & UPJOHN COMPANY LLC]	26	Current NDC, Legacy NDC, 1 package rows	20240831_a586be28-96af-4fed-a13f-9b94fd4c7405.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Provera	MEDROXYPROGESTERONE ACETATE	Pharmacia & Upjohn Company LLC	a586be28-96af-4fed-a13f-9b94fd4c7405	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 011839 application number: NDA011839 ndc (product): 0009-0065
medroxyprogesterone acetate	MEDROXYPROGESTERONE ACETATE	Mylan Pharmaceuticals Inc.	2627eb11-06bf-4a45-9172-094468e3ca07	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 011839 application number: NDA011839

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C2QI4IOI2G	MEDROXYPROGESTERONE ACETATE	71-58-9	MEDROXYPROGESTERONE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1000114	medroxyPROGESTERone acetate 10 MG Oral Tablet	PSN	a586be28-96af-4fed-a13f-9b94fd4c7405	26
1000135	medroxyPROGESTERone acetate 2.5 MG Oral Tablet	PSN	a586be28-96af-4fed-a13f-9b94fd4c7405	26
1000141	medroxyPROGESTERone acetate 5 MG Oral Tablet	PSN	a586be28-96af-4fed-a13f-9b94fd4c7405	26
1000124	Provera 10 MG Oral Tablet	PSN	a586be28-96af-4fed-a13f-9b94fd4c7405	26
1000139	Provera 2.5 MG Oral Tablet	PSN	a586be28-96af-4fed-a13f-9b94fd4c7405	26
1000145	Provera 5 MG Oral Tablet	PSN	a586be28-96af-4fed-a13f-9b94fd4c7405	26
1000124	medroxyprogesterone acetate 10 MG Oral Tablet [Provera]	SBD	a586be28-96af-4fed-a13f-9b94fd4c7405	26
1000139	medroxyprogesterone acetate 2.5 MG Oral Tablet [Provera]	SBD	a586be28-96af-4fed-a13f-9b94fd4c7405	26
1000145	medroxyprogesterone acetate 5 MG Oral Tablet [Provera]	SBD	a586be28-96af-4fed-a13f-9b94fd4c7405	26
1000114	medroxyprogesterone acetate 10 MG Oral Tablet	SCD	a586be28-96af-4fed-a13f-9b94fd4c7405	26
1000135	medroxyprogesterone acetate 2.5 MG Oral Tablet	SCD	a586be28-96af-4fed-a13f-9b94fd4c7405	26
1000141	medroxyprogesterone acetate 5 MG Oral Tablet	SCD	a586be28-96af-4fed-a13f-9b94fd4c7405	26
1000124	Provera 10 MG Oral Tablet	SY	a586be28-96af-4fed-a13f-9b94fd4c7405	26
1000139	Provera 2.5 MG Oral Tablet	SY	a586be28-96af-4fed-a13f-9b94fd4c7405	26
1000145	Provera 5 MG Oral Tablet	SY	a586be28-96af-4fed-a13f-9b94fd4c7405	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0009-0065-01	00009006501	100 TABLET in 1 BOTTLE (0009-0065-01)	100 tablet	2019-09-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROVERA® (medroxyprogesterone acetate tablets, USP)	Pharmacia & Upjohn Company LLC \| Pfizer Italia S.r.l.	2026-06-29	HUMAN PRESCRIPTION DRUG LABEL	27