Home NDC 70954-522 INZIRQO
Product NDC 70954-522
11-digit product format 709540522
Labeler code 70954
Product ID 70954-522_d6ace9b2-f8fa-42b9-8338-9e2b5519ef6b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydrochlorothiazide
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application NDA219141
Marketing category NDA
Marketing start 2025-01-30
Substance HYDROCHLOROTHIAZIDE
Active strength 10 mg/mL
Pharmacologic classes Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [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 43 .
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 N219141-001 INZIRQO HYDROCHLOROTHIAZIDE 10MG/ML FOR SUSPENSION / ORAL RLD, RS 2025-01-28
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 N219141-001 11878022 2044-01-23 U-4138 Drug product 2025-02-28 N219141-001 11878022 2044-01-23 U-4139 Drug product 2025-02-28
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 2026-09-14 22:38:34 2026-08 N219141-001 INZIRQO 10MG/ML FOR SUSPENSION / ORAL RLD, RS 2025-01-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219141-001 INZIRQO 10MG/ML FOR SUSPENSION / ORAL RLD, RS 2025-01-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219141-001 INZIRQO 10MG/ML FOR SUSPENSION / ORAL RLD, RS 2025-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219141-001 INZIRQO 10MG/ML FOR SUSPENSION / ORAL RLD, RS 2025-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219141-001 INZIRQO 10MG/ML FOR SUSPENSION / ORAL RLD, RS 2025-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219141-001 INZIRQO 10MG/ML FOR SUSPENSION / ORAL RLD, RS 2025-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N219141-001 INZIRQO 10MG/ML FOR SUSPENSION / ORAL RLD, RS 2025-01-28 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219141-001 INZIRQO 10MG/ML FOR SUSPENSION / ORAL RLD, RS 2025-01-28 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 2026-09-14 22:38:34 2026-08 N219141-001 11878022 2044-01-23 U-4138 Drug product 2025-02-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219141-001 11878022 2044-01-23 U-4139 Drug product 2025-02-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219141-001 11878022 2044-01-23 U-4138 Drug product 2025-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219141-001 11878022 2044-01-23 U-4139 Drug product 2025-02-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219141-001 11878022 2044-01-23 U-4138 Drug product 2025-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219141-001 11878022 2044-01-23 U-4139 Drug product 2025-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219141-001 11878022 2044-01-23 U-4138 Drug product 2025-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219141-001 11878022 2044-01-23 U-4139 Drug product 2025-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219141-001 11878022 2044-01-23 U-4138 Drug product 2025-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219141-001 11878022 2044-01-23 U-4139 Drug product 2025-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219141-001 11878022 2044-01-23 U-4138 Drug product 2025-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219141-001 11878022 2044-01-23 U-4139 Drug product 2025-02-28 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219141-001 11878022 2044-01-23 U-4138 Drug product 2025-02-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219141-001 11878022 2044-01-23 U-4139 Drug product 2025-02-28 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base INZIRQO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCHLOROTHIAZIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2704012 Internal RxNorm lookup 2704018 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 70954-522-10 INZIRQO 80 mL in 1 BOTTLE POWDER, FOR SUSPENSION 80 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-522 INZIRQO (HYDROCHLOROTHIAZIDE) POWDER, FOR SUSPENSION [ANI PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20250206_41aaea48-6c1b-42c8-a96f-5923d49dc934.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 70954-522-10 70954052210 80 mL in 1 BOTTLE (70954-522-10) 80 ml 2025-01-30 No No Current