Home NDC 0009-4709 Depo-SubQ Provera
Product NDC 0009-4709
11-digit product format 000094709
Labeler code 0009
Product ID 0009-4709_641b0fea-8376-4405-aea2-ac972c4a65eb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name medroxyprogesterone acetate
Dosage form INJECTION, SUSPENSION
Route SUBCUTANEOUS
Labeler Pharmacia & Upjohn Company LLC
Application NDA021583
Marketing category NDA
Marketing start 2005-05-02
Substance MEDROXYPROGESTERONE ACETATE
Active strength 104 mg/.65mL
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021583-001 DEPO-SUBQ PROVERA 104 MEDROXYPROGESTERONE ACETATE 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17
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 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021583-001 DEPO-SUBQ PROVERA 104 104MG/0.65ML INJECTABLE / SUBCUTANEOUS RLD, RS 2004-12-17 e64feba35796…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021583-001 6495534 2020-05-15 Drug product 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N021583-001 6495534 2020-05-15 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021583-001 6495534 2020-05-15 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021583-001 6495534 2020-05-15 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021583-001 6495534 2020-05-15 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021583-001 6495534 2020-05-15 Drug product ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Depo-SubQ Provera
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEDROXYPROGESTERONE ACETATE 104 mg/.65mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000156 Internal RxNorm lookup 1000158 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0009-4709-13 Depo-SubQ Provera 0.65 mL in 1 SYRINGE INJECTION, SUSPENSION 0.65 21 0009-4709-13 Depo-SubQ Provera 1 in 1 CARTON INJECTION, SUSPENSION 1 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MEDROXYPROGESTERONE ACETATE ACTIVE INGREDIENT C2QI4IOI2G DEPO-SUBQ PROVERA (MEDROXYPROGESTERONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY] 11 MEDROXYPROGESTERONE ACTIVE MOIETY HSU1C9YRES DEPO-SUBQ PROVERA (MEDROXYPROGESTERONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY] 11 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB DEPO-SUBQ PROVERA (MEDROXYPROGESTERONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY] 11 METHIONINE INACTIVE INGREDIENT AE28F7PNPL DEPO-SUBQ PROVERA (MEDROXYPROGESTERONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY] 11 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T DEPO-SUBQ PROVERA (MEDROXYPROGESTERONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY] 11 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DEPO-SUBQ PROVERA (MEDROXYPROGESTERONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY] 11 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H DEPO-SUBQ PROVERA (MEDROXYPROGESTERONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY] 11 POVIDONES INACTIVE INGREDIENT FZ989GH94E DEPO-SUBQ PROVERA (MEDROXYPROGESTERONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY] 11 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH DEPO-SUBQ PROVERA (MEDROXYPROGESTERONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY] 11 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X DEPO-SUBQ PROVERA (MEDROXYPROGESTERONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY] 11 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I DEPO-SUBQ PROVERA (MEDROXYPROGESTERONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY] 11 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F DEPO-SUBQ PROVERA (MEDROXYPROGESTERONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY] 11 SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS INACTIVE INGREDIENT KH7I04HPUU DEPO-SUBQ PROVERA (MEDROXYPROGESTERONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY] 11 WATER INACTIVE INGREDIENT 059QF0KO0R DEPO-SUBQ PROVERA (MEDROXYPROGESTERONE ACETATE) INJECTION, SUSPENSION [PHARMACIA AND UPJOHN COMPANY] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0009-4709 DEPO-SUBQ PROVERA (MEDROXYPROGESTERONE ACETATE) INJECTION, SUSPENSION [PHARMACIA & UPJOHN COMPANY LLC] 19 Current NDC, Legacy NDC, 2 package rows 20241228_390087a6-f3c3-4f0b-a930-79acf412f153.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.
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 0009-4709-13 00009470913 1 SYRINGE in 1 CARTON (0009-4709-13) / .65 mL in 1 SYRINGE 1 syringe 2005-05-02 0000-00-00 No No Current