Home NDC 70518-4324 medroxyprogesterone acetate
Product NDC 70518-4324
11-digit product format 705184324
Labeler code 70518
Product ID 70518-4324_402efbd6-18cd-3037-e063-6394a90a5c81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name medroxyprogesterone acetate
Dosage form INJECTION, SUSPENSION
Route INTRAMUSCULAR
Labeler REMEDYREPACK INC.
Application ANDA215397
Marketing category ANDA
Marketing start 2025-04-01
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 A215397-001 MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215397-001 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.
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 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215397-001 MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE / INJECTION AB 2023-06-07 a50c72e98297…
Observed Orange Book normalized TE history# 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 1000153 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 70518-4324-0 medroxyprogesterone acetate 1 in 1 CARTON INJECTION, SUSPENSION 1 2 70518-4324-0 medroxyprogesterone acetate 1 mL in 1 SYRINGE, GLASS INJECTION, SUSPENSION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4324 MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [REMEDYREPACK INC.] 1 Current NDC, 2 package rows 20250406_a0a92717-c1cb-40eb-a95a-1c5dfd32cfc0.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70518-4324-0 70518432400 1 SYRINGE, GLASS in 1 CARTON (70518-4324-0) / 1 mL in 1 SYRINGE, GLASS 2025-04-01 No No Current