FDA.reportPublic FDA data

medroxyprogesterone acetate

Product NDC
70121-1467
11-digit product format
701211467
Labeler code
70121
Product ID
70121-1467_391fd062-e255-4396-aaff-027344c3a39d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
medroxyprogesterone acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA215397
Marketing category
ANDA
Marketing start
2023-06-13
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215397-001MEDROXYPROGESTERONE ACETATEMEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215397-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-078072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-073f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215397-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2023-06-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A215397-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215397-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215397-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215397-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215397-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215397-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215397-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215397-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215397-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215397-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215397-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215397-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215397-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215397-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215397-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215397-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215397-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215397-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215397-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215397-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215397-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215397-001AB13f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215397-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
medroxyprogesterone acetate
Listing expiration
2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000126Internal RxNorm lookup
1000153Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6457d70a-2f25-4935-8511-726d988f7a03Available 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
70121-1467-2medroxyprogesterone acetate1 mL in 1 VIALINJECTION, SUSPENSION17
70121-1467-2medroxyprogesterone acetate1 in 1 CARTONINJECTION, SUSPENSION17
70121-1467-5medroxyprogesterone acetate1 mL in 1 VIALINJECTION, SUSPENSION17
70121-1467-5medroxyprogesterone acetate25 in 1 CARTONINJECTION, SUSPENSION257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1467-2ML - Milliliter70121-146716097109-6c04-442c-9004-a9bd9b98427e12023-09-05
70121-1467-5ML - Milliliter70121-1467e70b481d-4a74-488e-b6a4-2ce3308aa1cb12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1467MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [AMNEAL PHARMACEUTICALS LLC]5Current NDC, 4 package rows20241117_6457d70a-2f25-4935-8511-726d988f7a03.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEAmneal Pharmaceuticals LLC6457d70a-2f25-4935-8511-726d988f7a032026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215397
application number: ANDA215397
ndc (product): 70121-1467
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEREMEDYREPACK INC.a0a92717-c1cb-40eb-a95a-1c5dfd32cfc02025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215397
application number: ANDA215397

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000126medroxyPROGESTERone acetate 150 MG in 1 ML InjectionPSN6457d70a-2f25-4935-8511-726d988f7a037
1000153medroxyPROGESTERone acetate 150 MG in 1 ML Prefilled SyringePSN6457d70a-2f25-4935-8511-726d988f7a037
10001261 ML medroxyprogesterone acetate 150 MG/ML InjectionSCD6457d70a-2f25-4935-8511-726d988f7a037
10001531 ML medroxyprogesterone acetate 150 MG/ML Prefilled SyringeSCD6457d70a-2f25-4935-8511-726d988f7a037
1000126medroxyprogesterone acetate 150 MG per 1 ML InjectionSY6457d70a-2f25-4935-8511-726d988f7a037
1000153medroxyprogesterone acetate 150 MG per 1 ML Prefilled SyringeSY6457d70a-2f25-4935-8511-726d988f7a037

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70121-1467-2701211467021 VIAL in 1 CARTON (70121-1467-2) / 1 mL in 1 VIAL1 vial2023-06-13NoNoCurrent
70121-1467-57012114670525 VIAL in 1 CARTON (70121-1467-5) / 1 mL in 1 VIAL25 vial2023-06-13NoNoCurrent