Home NDC 71863-116 Khindivi
Product NDC 71863-116
11-digit product format 718630116
Labeler code 71863
Product ID 71863-116_4e6ce593-4984-4a6f-e063-6394a90a0169
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone
Dosage form SOLUTION
Route ORAL
Labeler Eton Pharmaceuticals, Inc.
Application NDA218980
Marketing category NDA
Marketing start 2025-06-02
Substance HYDROCORTISONE
Active strength 1 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218980-001 KHINDIVI HYDROCORTISONE 1MG/ML SOLUTION / ORAL RLD, RS 2025-05-28
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218980-001 11904046 2043-02-23 U-4216 Drug product 2025-07-23 N218980-001 12133914 2043-02-23 U-4215 2025-07-23
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 N218980-001 KHINDIVI 1MG/ML SOLUTION / ORAL RLD, RS 2025-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218980-001 KHINDIVI 1MG/ML SOLUTION / ORAL RLD, RS 2025-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218980-001 KHINDIVI 1MG/ML SOLUTION / ORAL RLD, RS 2025-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218980-001 KHINDIVI 1MG/ML SOLUTION / ORAL RLD, RS 2025-05-28 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218980-001 KHINDIVI 1MG/ML SOLUTION / ORAL RLD, RS 2025-05-28 a50c72e98297…
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 2026-08-18 06:07:40 2026-07 N218980-001 11904046 2043-02-23 U-4216 Drug product 2025-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218980-001 12133914 2043-02-23 U-4215 2025-07-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218980-001 11904046 2043-02-23 U-4216 Drug product 2025-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218980-001 12133914 2043-02-23 U-4215 2025-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218980-001 11904046 2043-02-23 U-4216 Drug product 2025-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218980-001 12133914 2043-02-23 U-4215 2025-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218980-001 11904046 2043-02-23 U-4216 Drug product 2025-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218980-001 12133914 2043-02-23 U-4215 2025-07-23 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218980-001 11904046 2043-02-23 U-4216 Drug product 2025-07-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218980-001 12133914 2043-02-23 U-4215 2025-07-23 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Khindivi
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2716550 Internal RxNorm lookup 2716556 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 71863-116-16 Khindivi 1 mL in 1 BOTTLE SOLUTION 1 4
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 71863-116-16 71863011616 1 mL in 1 BOTTLE (71863-116-16) 1 ml 2025-06-02 No No Current