Medroxyprogesterone Acetate

Product NDC
60219-1467
11-digit product format
602191467
Labeler code
60219
Product ID
60219-1467_b18868d1-e830-4990-a0f2-66210a783d39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA210227
Marketing category
ANDA
Marketing start
2025-06-10
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210227-001MEDROXYPROGESTERONE ACETATEMEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210227-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-123f01610625f2…
2019-09-15 20:21 UTC2019-09A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210227-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2018-10-12e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210227-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210227-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210227-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210227-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210227-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210227-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210227-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210227-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210227-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210227-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210227-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210227-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210227-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210227-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210227-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210227-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210227-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210227-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210227-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210227-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210227-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210227-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A210227-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210227-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210227-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210227-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A210227-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A210227-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210227-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210227-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210227-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210227-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210227-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210227-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210227-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210227-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210227-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210227-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210227-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210227-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Medroxyprogesterone Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEDROXYPROGESTERONE ACETATE150 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C2QI4IOI2GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000126Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a80560e1-96dd-4380-b3e1-d52719ccdd4bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dceProduct name620240606
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2Product name120140508
51a98800-9a04-9e42-2219-e588f17f9e48Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
f363ed61-d8ad-8f59-ee92-52a12578e008Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-1467-1Medroxyprogesterone Acetate1 in 1 CARTONINJECTION, SUSPENSION13
60219-1467-1Medroxyprogesterone Acetate1 mL in 1 VIALINJECTION, SUSPENSION13
60219-1467-2Medroxyprogesterone Acetate1 mL in 1 VIALINJECTION, SUSPENSION13
60219-1467-2Medroxyprogesterone Acetate25 in 1 CARTONINJECTION, SUSPENSION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-1467-1ML - Milliliter60219-1467b9105793-36ae-4d6c-a0b4-482eb9b384ec12025-11-13

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEXiromed LLC24544a5d-0cf5-a099-b57c-6e0843a405322026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210227
application number: ANDA210227
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEAmneal Pharmaceuticals NY LLCa80560e1-96dd-4380-b3e1-d52719ccdd4b2025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210227
application number: ANDA210227
ndc (product): 60219-1467
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEMylan Institutional LLC60aba812-59eb-4d40-9b6b-d135dca9d36b2021-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210227
application number: ANDA210227

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000126medroxyPROGESTERone acetate 150 MG in 1 ML InjectionPSNa80560e1-96dd-4380-b3e1-d52719ccdd4b3
10001261 ML medroxyprogesterone acetate 150 MG/ML InjectionSCDa80560e1-96dd-4380-b3e1-d52719ccdd4b3
1000126medroxyprogesterone acetate 150 MG per 1 ML InjectionSYa80560e1-96dd-4380-b3e1-d52719ccdd4b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60219-1467-1602191467011 VIAL in 1 CARTON (60219-1467-1) / 1 mL in 1 VIAL1 vial2025-06-10NoNoCurrent
60219-1467-26021914670225 VIAL in 1 CARTON (60219-1467-2) / 1 mL in 1 VIAL25 vial2025-06-10NoNoCurrent