FDA.reportPublic FDA data

0.65 ML medroxyprogesterone acetate 160 MG/ML Prefilled Syringe [depo-subQ provera]

RxCUI
1000158
RxNorm name
0.65 ML medroxyprogesterone acetate 160 MG/ML Prefilled Syringe [depo-subQ provera]
Display name
DEPO-SUBQ PROVERA (Injectable)
Full name
0.65 ML medroxyprogesterone acetate 160 MG/ML Prefilled Syringe [depo-subQ provera]
Term type
SBD
Status
Active
Strength
160 mg/ml
Dose form
Prefilled Syringe 0.65 ml
Route
Injectable
Updated
2026-10-21 07:27:00

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092010
Active start
092010
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
medroxyprogesterone acetate160 MG / 1 MLmedroxyprogesteronemedroxyprogesterone acetate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Prefilled Syringe721656

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
medroxyprogesterone6691

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STR0.65 ML depo-subQ provera 160 MG/ML Prefilled Syringe1NAMES
RxNorm Name0.65 ML medroxyprogesterone acetate 160 MG/ML Prefilled Syringe [depo-subQ provera]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID390087a6-f3c3-4f0b-a930-79acf412f1531CODES
RxCUI10001581CODES
MMSL_CODEBD148661CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0009-4709-130009-4709Depo-SubQ Provera medroxyprogesterone acetatePharmacia & Upjohn Company LLCNDA021583

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA0215830009-4709Depo-SubQ Provera medroxyprogesterone acetateNDAPharmacia & Upjohn Company LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 5 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00009470913rxnav_ndcsyes
00009470901rxnav_historical
54569621900rxnav_historical
59267470901rxnav_historical
59267470909rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
Depo-SubQ ProveraMEDROXYPROGESTERONE ACETATEPharmacia & Upjohn Company LLC390087a6-f3c3-4f0b-a930-79acf412f1532025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 0009-4709-13
ndc (product): 0009-4709
ndc11 (package): 00009470913
rxcui: 1000158

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
390087a6-f3c3-4f0b-a930-79acf412f153depo-subQ provera 104 MG in 0.65 ML Prefilled Syringe [PSN] · 0.65 ML medroxyprogesterone acetate 160 MG/ML Prefilled Syringe [depo-subQ provera] [SBD] · 0.65 ML depo-subQ provera 160 MG/ML Prefilled Syringe [SY] · depo-subQ provera 104 MG per 0.65 ML Prefilled Syringe [SY]421These highlights do not include all the information needed to use DEPO-SUBQ PROVERA 104 ® safely and effectively. See full prescribing information for DEPO-SUBQ PROVERA 104. DEPO-SUBQ PROVERA 104 (medroxyprogesterone acetate) injectable suspension, for subcutaneous use Initial U.S. Approval: 195920251218

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
390087a6-f3c3-4f0b-a930-79acf412f153These highlights do not include all the information needed to use DEPO-SUBQ PROVERA 104 ® safely and effectively. See full prescribing information for DEPO-SUBQ PROVERA 104. DEPO-SUBQ PROVERA 104 (medroxyprogesterone acetate) injectable suspension, for subcutaneous use Initial U.S. Approval: 1959Pharmacia & Upjohn Company LLC | Pfizer Manufacturing Belgium NV20251218
390087a6-f3c3-4f0b-a930-79acf412f153These highlights do not include all the information needed to use DEPO-SUBQ PROVERA 104 ® safely and effectively. See full prescribing information for DEPO-SUBQ PROVERA 104. DEPO-SUBQ PROVERA 104 (medroxyprogesterone acetate) injectable suspension, for subcutaneous use Initial U.S. Approval: 1959Pharmacia & Upjohn Company LLC | Pfizer Manufacturing Belgium NV20250902
8944900a-1fe4-40f3-af0e-e90de8971cecNational Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCG03DAPregnen (4) derivativesATC1-4medroxyprogesterone
ATCL02ABProgestogensATC1-4medroxyprogesterone
ATCG03ACProgestogensATC1-4medroxyprogesterone
FDASPLD045167Progesterone CongenersCHEMhas_chemical_structuremedroxyprogesterone
FDASPLN0000175602ProgestinEPChas_epcmedroxyprogesterone
MEDRTD008525MedroxyprogesteroneCHEMhas_ingredientmedroxyprogesterone
MEDRTD017258Medroxyprogesterone AcetateCHEMhas_ingredientmedroxyprogesterone acetate
MEDRTD000568AmenorrheaDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD000568AmenorrheaDISEASEmay_treatmedroxyprogesterone
MEDRTD001943Breast NeoplasmsDISEASEmay_treatmedroxyprogesterone
MEDRTD001943Breast NeoplasmsDISEASEci_withmedroxyprogesterone
MEDRTD001943Breast NeoplasmsDISEASEci_withmedroxyprogesterone acetate
MEDRTD001943Breast NeoplasmsDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD002292Carcinoma, Renal CellDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD002292Carcinoma, Renal CellDISEASEmay_treatmedroxyprogesterone
MEDRTD002543Cerebral HemorrhageDISEASEci_withmedroxyprogesterone acetate
MEDRTD002543Cerebral HemorrhageDISEASEci_withmedroxyprogesterone
MEDRTD004342Drug HypersensitivityDISEASEci_withmedroxyprogesterone acetate
MEDRTD004342Drug HypersensitivityDISEASEci_withmedroxyprogesterone
MEDRTD004714Endometrial HyperplasiaDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD004714Endometrial HyperplasiaDISEASEmay_treatmedroxyprogesterone
MEDRTD016889Endometrial NeoplasmsDISEASEmay_treatmedroxyprogesterone
MEDRTD016889Endometrial NeoplasmsDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD006470HemorrhageDISEASEci_withmedroxyprogesterone
MEDRTD006470HemorrhageDISEASEci_withmedroxyprogesterone acetate
MEDRTD007040HypoventilationDISEASEmay_treatmedroxyprogesterone
MEDRTD007040HypoventilationDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD008107Liver DiseasesDISEASEci_withmedroxyprogesterone acetate
MEDRTD008107Liver DiseasesDISEASEci_withmedroxyprogesterone
MEDRTD009376Neoplasms, Hormone-DependentDISEASEci_withmedroxyprogesterone acetate
MEDRTD009376Neoplasms, Hormone-DependentDISEASEci_withmedroxyprogesterone
MEDRTD011247PregnancyDISEASEmay_preventmedroxyprogesterone acetate
MEDRTD011247PregnancyDISEASEmay_preventmedroxyprogesterone
MEDRTD011247PregnancyDISEASEci_withmedroxyprogesterone
MEDRTD011247PregnancyDISEASEci_withmedroxyprogesterone acetate
MEDRTD011655Pulmonary EmbolismDISEASEci_withmedroxyprogesterone acetate
MEDRTD011655Pulmonary EmbolismDISEASEci_withmedroxyprogesterone
MEDRTD013924ThrombophlebitisDISEASEci_withmedroxyprogesterone acetate
MEDRTD013924ThrombophlebitisDISEASEci_withmedroxyprogesterone
MEDRTD014592Uterine HemorrhageDISEASEci_withmedroxyprogesterone
MEDRTD014592Uterine HemorrhageDISEASEci_withmedroxyprogesterone acetate
MEDRTD014592Uterine HemorrhageDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD014592Uterine HemorrhageDISEASEmay_treatmedroxyprogesterone
MEDRTD014623Vaginal DiseasesDISEASEci_withmedroxyprogesterone
MEDRTD014623Vaginal DiseasesDISEASEci_withmedroxyprogesterone acetate
MEDRTD020246Venous ThrombosisDISEASEci_withmedroxyprogesterone
MEDRTD020246Venous ThrombosisDISEASEci_withmedroxyprogesterone acetate
MEDRTN0000000185Progestational Hormone Receptor AgonistsMOAhas_moamedroxyprogesterone acetate
MEDRTN0000000185Progestational Hormone Receptor AgonistsMOAhas_moamedroxyprogesterone
MEDRTN0000008630Decreased Follicle Stimulating Hormone SecretionPEhas_pemedroxyprogesterone acetate
MEDRTN0000008630Decreased Follicle Stimulating Hormone SecretionPEhas_pemedroxyprogesterone
MEDRTN0000008632Decreased Growth Hormone SecretionPEhas_pemedroxyprogesterone acetate
MEDRTN0000008632Decreased Growth Hormone SecretionPEhas_pemedroxyprogesterone
MEDRTN0000009051Gonadotropin Releasing Hormone AlterationPEhas_pemedroxyprogesterone acetate
MEDRTN0000009051Gonadotropin Releasing Hormone AlterationPEhas_pemedroxyprogesterone
MEDRTN0000009715Inhibit Ovarian Follicular PhasePEhas_pemedroxyprogesterone acetate
MEDRTN0000009715Inhibit Ovarian Follicular PhasePEhas_pemedroxyprogesterone
MEDRTN0000009717Inhibit OvulationPEhas_pemedroxyprogesterone acetate
MEDRTN0000009717Inhibit OvulationPEhas_pemedroxyprogesterone
MEDRTN0000009857Stimulate Breast Glandular DevelopmentPEhas_pemedroxyprogesterone acetate
MEDRTN0000009857Stimulate Breast Glandular DevelopmentPEhas_pemedroxyprogesterone
MEDRTN0000000043Hepatic ExcretionPKhas_pkmedroxyprogesterone
MEDRTN0000000043Hepatic ExcretionPKhas_pkmedroxyprogesterone acetate
MEDRTN0000000026Hepatic MetabolismPKhas_pkmedroxyprogesterone
MEDRTN0000000026Hepatic MetabolismPKhas_pkmedroxyprogesterone acetate
MEDRTN0000000042Renal ExcretionPKhas_pkmedroxyprogesterone
MEDRTN0000000042Renal ExcretionPKhas_pkmedroxyprogesterone acetate

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH160 MG/ML (expressed as medroxyprogesterone acetate)
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY0.65 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA021583
NAMESPrescribable Synonymdepo-subQ provera 104 MG in 0.65 ML Prefilled Syringe
NAMESTallman Synonym0.65 ML medroxyPROGESTERone acetate 160 MG/ML Prefilled Syringe [depo-subQ provera]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon