Home NDC 67457-887 Medroxyprogesterone Acetate
Product NDC 67457-887
11-digit product format 674570887
Labeler code 67457
Product ID 67457-887_e991ce3c-100b-2015-f61e-676217681e0f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Medroxyprogesterone Acetate
Dosage form INJECTION, SUSPENSION
Route INTRAMUSCULAR
Labeler Mylan Institutional LLC
Application ANDA210227
Marketing category ANDA
Marketing start 2018-10-12
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210227-001 MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210227-001 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 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210227-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2018-10-12 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 2026-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67457-887-00 Medroxyprogesterone Acetate 1 mL in 1 VIAL INJECTION, SUSPENSION 1 8 67457-887-01 Medroxyprogesterone Acetate 25 in 1 CARTON INJECTION, SUSPENSION 25 8 67457-887-99 Medroxyprogesterone Acetate 1 in 1 CARTON INJECTION, SUSPENSION 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-887 MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [MYLAN INSTITUTIONAL LLC] 7 Current NDC, Legacy NDC, 3 package rows 20250221_60aba812-59eb-4d40-9b6b-d135dca9d36b.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 · 3 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 67457-887-00 67457088700 1 mL in 1 VIAL 1 ml Historical 67457-887-01 67457088701 25 VIAL in 1 CARTON (67457-887-01) / 1 mL in 1 VIAL (67457-887-00) 25 vial 2018-10-12 0000-00-00 No No Current 67457-887-99 67457088799 1 VIAL in 1 CARTON (67457-887-99) / 1 mL in 1 VIAL (67457-887-00) 1 vial 2018-10-12 0000-00-00 No No Current