FDA.reportPublic FDA data

Medroxyprogesterone Acetate Injectable Suspension

Product NDC
24201-150
11-digit product format
242010150
Labeler code
24201
Product ID
24201-150_3bf1d302-025e-447c-8480-065dd9f01849
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
medroxyprogesterone acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA214309
Marketing category
ANDA
Marketing start
2023-05-01
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
A214309-001MEDROXYPROGESTERONE ACETATEMEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-05

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-058072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-01-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-01-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-01-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-01-053bdfa0b2c4d7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214309-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2023-01-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214309-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214309-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A214309-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A214309-001AB13bdfa0b2c4d7…

Additional Listing Data#

Finished product
Yes
Brand name base
Medroxyprogesterone Acetate Injectable Suspension
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
0476eac5-d96c-4910-aa86-1ddeeefefe50Available 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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2Product name120140508
51a98800-9a04-9e42-2219-e588f17f9e48Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508
f363ed61-d8ad-8f59-ee92-52a12578e008Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24201-150-00Medroxyprogesterone Acetate Injectable Suspension1 mL in 1 VIALINJECTION, SUSPENSION13
24201-150-01Medroxyprogesterone Acetate Injectable Suspension1 in 1 CARTONINJECTION, SUSPENSION13
24201-150-25Medroxyprogesterone Acetate Injectable Suspension25 in 1 CARTONINJECTION, SUSPENSION253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24201-150MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION (MEDROXYPROGESTERONE ACETATE) INJECTION, SUSPENSION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, 3 package rows20250110_0476eac5-d96c-4910-aa86-1ddeeefefe50.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medroxyprogesterone Acetate Injectable SuspensionMEDROXYPROGESTERONE ACETATEHikma Pharmaceuticals USA Inc.0476eac5-d96c-4910-aa86-1ddeeefefe502025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214309
application number: ANDA214309
ndc (product): 24201-150

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000126medroxyPROGESTERone acetate 150 MG in 1 ML InjectionPSN0476eac5-d96c-4910-aa86-1ddeeefefe503
10001261 ML medroxyprogesterone acetate 150 MG/ML InjectionSCD0476eac5-d96c-4910-aa86-1ddeeefefe503
1000126medroxyprogesterone acetate 150 MG per 1 ML InjectionSY0476eac5-d96c-4910-aa86-1ddeeefefe503

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
24201-150-00242010150001 mL in 1 VIAL1 mlHistorical
24201-150-01242010150011 VIAL in 1 CARTON (24201-150-01) / 1 mL in 1 VIAL (24201-150-00) 1 vial2023-05-01NoNoCurrent
24201-150-252420101502525 VIAL in 1 CARTON (24201-150-25) / 1 mL in 1 VIAL (24201-150-00) 25 vial2023-05-01NoNoCurrent