Medroxyprogesterone Acetate

Product NDC: 70700-315
11-digit product format: 707000315
Labeler code: 70700
Product ID: 70700-315_4f9af826-fda5-ed08-e063-6294a90a6b29
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Medroxyprogesterone Acetate
Dosage form: INJECTION, SUSPENSION
Route: INTRAMUSCULAR
Labeler: Xiromed LLC
Application: ANDA210227
Marketing category: ANDA
Marketing start: 2024-03-12
Substance: MEDROXYPROGESTERONE ACETATE
Active strength: 150 mg/mL
Pharmacologic classes: Progesterone Congeners [CS], Progestin [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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210227-001	MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB		2018-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210227-001	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 2 · 42 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	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210227-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2018-10-12	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A210227-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210227-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210227-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210227-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210227-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210227-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210227-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210227-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210227-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210227-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210227-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210227-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210227-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210227-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210227-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210227-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210227-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210227-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210227-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210227-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210227-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210227-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210227-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210227-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210227-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210227-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210227-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210227-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210227-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210227-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210227-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210227-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210227-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210227-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210227-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210227-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210227-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210227-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210227-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210227-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEDROXYPROGESTERONE ACETATE	150 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000126	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
24544a5d-0cf5-a099-b57c-6e0843a40532	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
882e78d5-69f7-4a43-812f-1c1628241bbc	Product name	1	20150910
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2	Product name	1	20140508
51a98800-9a04-9e42-2219-e588f17f9e48	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	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	SPL version
70700-315-22	Medroxyprogesterone Acetate	1 mL in 1 CONTAINER	INJECTION, SUSPENSION	1	6
70700-315-25	Medroxyprogesterone Acetate	25 in 1 CARTON	INJECTION, SUSPENSION	25	6
70700-315-25	Medroxyprogesterone Acetate	1 mL in 1 VIAL	INJECTION, SUSPENSION	1	6
70700-315-27	Medroxyprogesterone Acetate	1 in 1 CARTON	INJECTION, SUSPENSION	1	6
70700-315-27	Medroxyprogesterone Acetate	1 mL in 1 VIAL	INJECTION, SUSPENSION	1	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70700-315-22	ML - Milliliter	70700-315	2eee8a0f-f784-4e10-9882-ba4f038014f1	1	2025-08-11
70700-315-25	ML - Milliliter	70700-315	23e690d4-a378-494c-86e3-063e87e76945	1	2025-05-14
70700-315-27	ML - Milliliter	70700-315	ad8e4eba-9297-4ec8-a4a7-741aa9679cef	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70700-315	MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [XIROMED LLC]	2	Current NDC, 5 package rows	20250123_24544a5d-0cf5-a099-b57c-6e0843a40532.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Xiromed LLC	24544a5d-0cf5-a099-b57c-6e0843a40532	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210227 application number: ANDA210227 ndc (product): 70700-315
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Amneal Pharmaceuticals NY LLC	a80560e1-96dd-4380-b3e1-d52719ccdd4b	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210227 application number: ANDA210227
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Mylan Institutional LLC	60aba812-59eb-4d40-9b6b-d135dca9d36b	2021-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210227 application number: ANDA210227

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
1000126	medroxyPROGESTERone acetate 150 MG in 1 ML Injection	PSN	24544a5d-0cf5-a099-b57c-6e0843a40532	6
1000126	1 ML medroxyprogesterone acetate 150 MG/ML Injection	SCD	24544a5d-0cf5-a099-b57c-6e0843a40532	6
1000126	medroxyprogesterone acetate 150 MG per 1 ML Injection	SY	24544a5d-0cf5-a099-b57c-6e0843a40532	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70700-315-22	70700031522	1 mL in 1 CONTAINER (70700-315-22)	1 ml	2024-03-12	No	No	Historical
70700-315-25	70700031525	25 VIAL in 1 CARTON (70700-315-25) / 1 mL in 1 VIAL	25 vial	2024-03-12	No	No	Current
70700-315-27	70700031527	1 VIAL in 1 CARTON (70700-315-27) / 1 mL in 1 VIAL	1 vial	2024-03-12	No	No	Current