Home NDC 70771-1966 Hydrocortisone sodium succinate
Product NDC 70771-1966
11-digit product format 707711966
Labeler code 70771
Product ID 70771-1966_23cd0282-fb6b-4fb9-9b3a-0b23e8125625
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone sodium succinate
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Zydus Lifesciences Limited
Application ANDA217191
Marketing category ANDA
Marketing start 2026-05-09
Substance HYDROCORTISONE SODIUM SUCCINATE
Active strength 100 mg/2mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217191-001 HYDROCORTISONE SODIUM SUCCINATE HYDROCORTISONE SODIUM SUCCINATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2026-05-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217191-001 AP
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 A217191-001 HYDROCORTISONE SODIUM SUCCINATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2026-05-07 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217191-001 HYDROCORTISONE SODIUM SUCCINATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2026-05-07 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A217191-001 AP 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217191-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Hydrocortisone sodium succinate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE SODIUM SUCCINATE 100 mg/2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 50LQB69S1Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238755 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 70771-1966-1 Hydrocortisone sodium succinate 1 in 1 CARTON INJECTION 1 1 70771-1966-1 Hydrocortisone sodium succinate 2 mL in 1 VIAL INJECTION 2 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 · 2 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 70771-1966-1 70771196601 1 VIAL in 1 CARTON (70771-1966-1) / 2 mL in 1 VIAL 1 vial 2026-05-09 No No Current