Medroxyprogesterone Acetate

Product NDC: 0548-5701
11-digit product format: 005485701
Labeler code: 0548
Product ID: 0548-5701_fe3eb29d-0024-4834-a1af-81661804f532
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Medroxyprogesterone acetate
Dosage form: INJECTION, SUSPENSION, EXTENDED RELEASE
Route: INTRAMUSCULAR
Labeler: Amphastar Pharmaceuticals, Inc.
Application: ANDA077334
Marketing category: ANDA
Marketing start: 2017-11-28
Substance: MEDROXYPROGESTERONE ACETATE
Active strength: 150 mg/mL
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 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
A077334-001	MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB		2017-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077334-001	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	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077334-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`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	A077334-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077334-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077334-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077334-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077334-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077334-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077334-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077334-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077334-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077334-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077334-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077334-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077334-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077334-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077334-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077334-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077334-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077334-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077334-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077334-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077334-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077334-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077334-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077334-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077334-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077334-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077334-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077334-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077334-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077334-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077334-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077334-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077334-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077334-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077334-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077334-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077334-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077334-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077334-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077334-001	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000126	Internal RxNorm lookup
1000153	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
fda1aa8a-5739-482a-b4f6-9741ef4d9977	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0548-5701-00	ML - Milliliter	0548-5701	ff0b2dae-6d0e-40b4-9201-c0f36d40cbe3	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0548-5701	MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION, EXTENDED RELEASE [AMPHASTAR PHARMACEUTICALS, INC.]	7	Current NDC, Legacy NDC	20211216_fda1aa8a-5739-482a-b4f6-9741ef4d9977.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
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Amphastar Pharmaceuticals, Inc.	fda1aa8a-5739-482a-b4f6-9741ef4d9977	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077334 application number: ANDA077334 ndc (product): 0548-5701

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0548-5701-00	00548570100	1 SYRINGE in 1 CARTON (0548-5701-00) / 1 mL in 1 SYRINGE	1 syringe	2017-11-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Medroxyprogesterone Acetate	Amphastar Pharmaceuticals, Inc.	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	9