Home NDC 0527-1413-01 Hydrochlorothiazide
Product NDC 0527-1413
Requested package NDC 0527-1413-01
11-digit product format 005271413
Labeler code 0527
Product ID 0527-1413_7ab02f2a-c630-488e-8395-cd83da05e565
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA084325
Marketing category ANDA
Marketing start 2007-05-01
Marketing end 0000-00-00
Substance HYDROCHLOROTHIAZIDE
Active strength 25 mg/1
Pharmacologic classes Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 A084325-001 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL Approved before 1982
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 A084325-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL Approved before 1982 a50c72e98297…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] 7 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] 7 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] 7 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] 7 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] 7 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] 7 HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] 5 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] 5 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] 5 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] 5 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] 5 HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] 1 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] 1
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 0527-1413-01 00527141301 100 TABLET in 1 BOTTLE, PLASTIC (0527-1413-01) 100 tablet 2007-05-01 0000-00-00 No No Current