Home NDC 63187-548 Hydrochlorothiazide
Product NDC 63187-548
11-digit product format 631870548
Labeler code 63187
Product ID 63187-548_75e914c5-6085-4f47-808b-f708657aa375
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrochlorothiazide
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Proficient Rx LP
Application NDA020504
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1996-12-27
Substance HYDROCHLOROTHIAZIDE
Active strength 12.5 mg/1
Pharmacologic classes Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 N020504-001 MICROZIDE HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020504-001 AB
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.
Product history page 1 of 2 · 42 observed 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 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020504-001 MICROZIDE 12.5MG CAPSULE / ORAL AB RLD, RS 1996-12-27 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Hydrochlorothiazide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCHLOROTHIAZIDE 12.5 mg/1
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199903 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 63187-548-07 Hydrochlorothiazide 07 in 1 BOTTLE CAPSULE, GELATIN COATED 07 6 63187-548-30 Hydrochlorothiazide 30 in 1 BOTTLE CAPSULE, GELATIN COATED 30 6 63187-548-60 Hydrochlorothiazide 60 in 1 BOTTLE CAPSULE, GELATIN COATED 60 6 63187-548-90 Hydrochlorothiazide 90 in 1 BOTTLE CAPSULE, GELATIN COATED 90 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP] 1 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-548 HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP] 6 Current NDC, Legacy NDC, 4 package rows 20230204_c1052d38-fd75-40c2-a685-0e889009be0b.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63187-548-07 63187054807 7 CAPSULE, GELATIN COATED in 1 BOTTLE (63187-548-07) 2017-05-01 0000-00-00 No No Current 63187-548-30 63187054830 30 CAPSULE, GELATIN COATED in 1 BOTTLE (63187-548-30) 2017-05-01 0000-00-00 No No Current 63187-548-60 63187054860 60 CAPSULE, GELATIN COATED in 1 BOTTLE (63187-548-60) 2017-05-01 0000-00-00 No No Current 63187-548-90 63187054890 90 CAPSULE, GELATIN COATED in 1 BOTTLE (63187-548-90) 2017-05-01 0000-00-00 No No Current