Home NDC 65145-192 Methylprednisolone Acetate
Product NDC 65145-192
11-digit product format 651450192
Labeler code 65145
Product ID 65145-192_23f98766-7571-49cb-8c1a-58fabba53965
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylprednisolone Acetate
Dosage form INJECTION, SUSPENSION
Route INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE
Labeler Caplin Steriles Limited
Application ANDA220556
Marketing category ANDA
Marketing start 2026-02-06
Substance METHYLPREDNISOLONE ACETATE
Active strength 40 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220556-001 METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2026-01-26 A220556-002 METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2026-01-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A220556-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2026-01-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220556-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2026-01-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A220556-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2026-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A220556-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2026-01-26 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220556-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2026-01-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220556-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2026-01-26 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Methylprednisolone Acetate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLPREDNISOLONE ACETATE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 43502P7F0P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1743779 Internal RxNorm lookup 1743855 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 65145-192-01 Methylprednisolone Acetate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SUSPENSION 1 1 65145-192-25 Methylprednisolone Acetate 25 in 1 CARTON INJECTION, SUSPENSION 25 1
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 Sample Exclude flag Status 65145-192-01 65145019201 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 65145-192-25 65145019225 25 VIAL, SINGLE-DOSE in 1 CARTON (65145-192-25) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-192-01) 2026-02-06 No No Current