Home NDC 51079-058 Chlorthalidone
Product NDC 51079-058
11-digit product format 510790058
Labeler code 51079
Product ID 51079-058_48d2cfb7-9e20-e6da-e063-6294a90a9254
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name chlorthalidone
Dosage form TABLET
Route ORAL
Labeler Mylan Institutional Inc.
Application ANDA086831
Marketing category ANDA
Marketing start 1998-06-12
Substance CHLORTHALIDONE
Active strength 25 mg/1
Pharmacologic classes Increased Diuresis [PE], Thiazide-like Diuretic [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 1 .
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 A086831-001 CHLORTHALIDONE CHLORTHALIDONE 50MG TABLET / ORAL AB RLD, RS, Approved before 1982 A086831-002 CHLORTHALIDONE CHLORTHALIDONE 25MG TABLET / ORAL AB RLD, Approved before 1982
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 2026-08-01 22:54:32 2026-06 A086831-001 CHLORTHALIDONE 50MG TABLET / ORAL AB RLD, RS, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 A086831-002 CHLORTHALIDONE 25MG TABLET / ORAL AB RLD, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A086831-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A086831-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Chlorthalidone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORTHALIDONE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q0MQD1073Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197499 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 51079-058-01 Chlorthalidone 1 in 1 BLISTER PACK TABLET 1 8 51079-058-20 Chlorthalidone 100 in 1 CARTON TABLET 100 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51079-058 CHLORTHALIDONE TABLET [MYLAN INSTITUTIONAL INC.] 6 Current NDC, Legacy NDC, 2 package rows 20211223_193c85ba-43c2-4be2-82cf-7b394a83390e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51079-058-01 51079005801 1 in 1 BLISTER PACK Historical 51079-058-20 51079005820 100 BLISTER PACK in 1 CARTON (51079-058-20) / 1 TABLET in 1 BLISTER PACK (51079-058-01) 100 blister pack 1998-06-12 0000-00-00 No No Current