Hydrochlorothiazide

Product NDC
0591-0347
Requested package NDC
0591-0347-01
11-digit product format
005910347
Labeler code
0591
Product ID
0591-0347_b062bc7e-af92-4648-aed1-e02568313e21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020504-001MICROZIDEHYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N020504-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-273f01610625f2…
2019-09-15 20:21 UTC2019-09N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-273f0d92c62455…
2023-05-13 08:27 UTC2023-05N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27053a50430f4f…
2023-01-26 05:58 UTC2023-01N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020504-001MICROZIDE12.5MGCAPSULE / ORALABRLD, RS1996-12-27cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020504-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020504-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020504-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020504-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020504-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020504-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020504-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020504-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020504-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020504-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020504-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020504-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020504-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020504-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020504-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020504-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020504-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020504-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020504-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020504-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020504-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020504-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020504-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020504-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020504-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020504-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020504-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020504-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020504-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020504-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020504-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020504-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020504-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020504-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020504-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020504-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020504-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020504-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020504-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020504-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrochlorothiazide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199903Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a3eb7294-f913-434b-896c-da028bfebc73Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-0347-01Hydrochlorothiazide100 in 1 BOTTLECAPSULE, GELATIN COATED10024
0591-0347-05Hydrochlorothiazide500 in 1 BOTTLECAPSULE, GELATIN COATED50024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0347-01EA - Each0591-0347c9282ce9-22fd-4fa7-81cf-de180d8770f412012-07-24
0591-0347-05EA - Each0591-03471a2d2b20-68f7-4659-b5bf-f697687ef4db12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]11
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]10
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]10
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]10
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]10
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]10
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PREFERRED PHARMACEUTICALS INC.]1
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PREFERRED PHARMACEUTICALS INC.]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PREFERRED PHARMACEUTICALS INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PREFERRED PHARMACEUTICALS INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PREFERRED PHARMACEUTICALS INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PREFERRED PHARMACEUTICALS INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PREFERRED PHARMACEUTICALS INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PREFERRED PHARMACEUTICALS INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PREFERRED PHARMACEUTICALS INC.]1
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PREFERRED PHARMACEUTICALS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PREFERRED PHARMACEUTICALS INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PREFERRED PHARMACEUTICALS INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PREFERRED PHARMACEUTICALS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PREFERRED PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0347HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]21Current NDC, Legacy NDC, 2 package rows20240509_a3eb7294-f913-434b-896c-da028bfebc73.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEQPharma, Inc.5bacc909-6b02-4815-85ef-55fd25b1b1f72025-12-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 020504
application number: NDA020504
HydrochlorothiazideHYDROCHLOROTHIAZIDEActavis Pharma, Inc.a3eb7294-f913-434b-896c-da028bfebc732024-08-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020504
application number: NDA020504
ndc (package): 0591-0347-01
ndc (product): 0591-0347
ndc11 (package): 00591034701
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LPc1052d38-fd75-40c2-a685-0e889009be0b2023-02-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020504
application number: NDA020504
HydrochlorothiazideHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC0f7a608d-748b-49a9-a4b3-b3fdcab53ce02017-12-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 020504
application number: NDA020504

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSNa3eb7294-f913-434b-896c-da028bfebc7324
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCDa3eb7294-f913-434b-896c-da028bfebc7324
199903HCTZ 12.5 MG Oral CapsuleSYa3eb7294-f913-434b-896c-da028bfebc7324
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN5bacc909-6b02-4815-85ef-55fd25b1b1f78
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD5bacc909-6b02-4815-85ef-55fd25b1b1f78
199903HCTZ 12.5 MG Oral CapsuleSY5bacc909-6b02-4815-85ef-55fd25b1b1f78
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSNc1052d38-fd75-40c2-a685-0e889009be0b6
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCDc1052d38-fd75-40c2-a685-0e889009be0b6
199903HCTZ 12.5 MG Oral CapsuleSYc1052d38-fd75-40c2-a685-0e889009be0b6
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN0f7a608d-748b-49a9-a4b3-b3fdcab53ce01
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN118f7c88-dd50-25d5-e054-00144ff88e881
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN1576a4be-c3ec-426e-9219-c6a0c99f294f1
310798hydroCHLOROthiazide 25 MG Oral TabletPSN118f7c88-dd6e-25d5-e054-00144ff88e881
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD1576a4be-c3ec-426e-9219-c6a0c99f294f1
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD118f7c88-dd50-25d5-e054-00144ff88e881
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD0f7a608d-748b-49a9-a4b3-b3fdcab53ce01
310798hydrochlorothiazide 25 MG Oral TabletSCD118f7c88-dd6e-25d5-e054-00144ff88e881
199903HCTZ 12.5 MG Oral CapsuleSY0f7a608d-748b-49a9-a4b3-b3fdcab53ce01
199903HCTZ 12.5 MG Oral CapsuleSY1576a4be-c3ec-426e-9219-c6a0c99f294f1
199903HCTZ 12.5 MG Oral CapsuleSY118f7c88-dd50-25d5-e054-00144ff88e881
310798HCTZ 25 MG Oral TabletSY118f7c88-dd6e-25d5-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-0347-0100591034701100 CAPSULE, GELATIN COATED in 1 BOTTLE (0591-0347-01) 1996-12-270000-00-00NoNoCurrent