Home NDC 50090-5619 medroxyprogesterone acetate
Product NDC 50090-5619
11-digit product format 500905619
Labeler code 50090
Product ID 50090-5619_30ad1e54-028e-498e-bb96-aa5f31235854
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name medroxyprogesterone acetate
Dosage form INJECTION, SUSPENSION
Route INTRAMUSCULAR
Labeler A-S Medication Solutions
Application NDA020246
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2021-07-06
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020246-001 DEPO-PROVERA MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020246-001 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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020246-001 DEPO-PROVERA 150MG/ML INJECTABLE / INJECTION AB RLD, RS 1992-10-29 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000126 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 50090-5619-0 2023-02-07 C162847 48780-1 f386c649-c209-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use MEDROXYPROGESTERONE ACETATE (MPA) Injectable Suspension, USP safely and effectively. See full prescribing information for MPA INJECTABLE SUSPENSION, USP. MEDROXYPROGESTERONE ACETATE (MPA) Injectable Suspension, USP, for intramuscular use Initial U.S. Approval: 1959 50090-5619-0 2023-01-30 C162847 48780-1 f386c649-c209-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use MEDROXYPROGESTERONE ACETATE (MPA) Injectable Suspension, USP safely and effectively. See full prescribing information for MPA INJECTABLE SUSPENSION, USP. MEDROXYPROGESTERONE ACETATE (MPA) Injectable Suspension, USP, for intramuscular use Initial U.S. Approval: 1959
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-5619-0 medroxyprogesterone acetate 1 mL in 1 VIAL INJECTION, SUSPENSION 1 6 50090-5619-0 medroxyprogesterone acetate 1 in 1 CARTON INJECTION, SUSPENSION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5619 MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS] 4 Current NDC, Legacy NDC, 2 package rows 20230208_5e817926-ba15-4d16-9463-88f6ff3bd3ac.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE Prasco Laboratories 987496bf-b4b0-409b-b745-f52ed0871f4e 2026-07-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020246 application number: NDA020246 medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE A-S Medication Solutions 5e817926-ba15-4d16-9463-88f6ff3bd3ac 2026-02-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020246 application number: NDA020246 ndc (product): 50090-5619 Depo-Provera MEDROXYPROGESTERONE ACETATE Pharmacia & Upjohn Company LLC 199cf13e-0859-4a73-9b45-e700d0cd1049 2025-12-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020246 application number: NDA020246 medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE A-S Medication Solutions ca344c55-5251-470f-9243-eceb9e496e3e 2023-10-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020246 application number: NDA020246
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-5619-0 50090561900 1 VIAL in 1 CARTON (50090-5619-0) / 1 mL in 1 VIAL 1 vial 2021-08-25 0000-00-00 No No Current