Home NDC 62484-0015-5 XROMI
Product NDC 62484-0015
Requested package NDC 62484-0015-5
11-digit product format 624840015
Labeler code 62484
Product ID 62484-0015_6eb58656-a29b-4edb-966f-bc9a13a78775
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyurea
Dosage form SOLUTION
Route ORAL
Labeler Nova Laboratories, Ltd.
Application NDA216593
Marketing category NDA
Marketing start 2024-04-04
Substance HYDROXYUREA
Active strength 100 mg/mL
Pharmacologic classes Antimetabolite [EPC], Urea [CS]
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 1 .
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 N216593-001 XROMI HYDROXYUREA 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216593-001 12409156 2041-12-23 Drug product 2025-09-26
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216593-001 NP 2027-04-04 N216593-001 ODE-470 2031-04-04
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 2026-02-19 14:30 UTC 2026-02 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216593-001 XROMI 100MG/ML SOLUTION / ORAL RLD, RS 2024-04-04 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 2026-02-19 14:30 UTC 2026-02 N216593-001 12409156 2041-12-23 Drug product 2025-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216593-001 12409156 2041-12-23 Drug product 2025-09-26 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216593-001 12409156 2041-12-23 Drug product 2025-09-26 a50c72e98297…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base XROMI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROXYUREA 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X6Q56QN5QC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2682741 Internal RxNorm lookup 2696079 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 62484-0015-4 XROMI 148 mL in 1 BOTTLE SOLUTION 148 10 62484-0015-5 XROMI 1 in 1 CARTON SOLUTION 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62484-0015 XROMI (HYDROXYUREA) SOLUTION [NOVA LABORATORIES, LTD.] 7 Current NDC, 2 package rows 20250105_4b37d336-86da-4363-aef1-34a7d3ba973b.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 · 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 62484-0015-5 62484001505 1 BOTTLE in 1 CARTON (62484-0015-5) / 148 mL in 1 BOTTLE (62484-0015-4) 1 bottle 2024-04-04 No No Current