FDA.reportPublic FDA data

Hydrochlorothiazide

Product NDC
29300-128
11-digit product format
293000128
Labeler code
29300
Product ID
29300-128_1e92de42-a7f2-4674-8260-28cfabf0759d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA040907
Marketing category
ANDA
Marketing start
2008-08-15
Substance
HYDROCHLOROTHIAZIDE
Active strength
25 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH
Rxcui197770, 310798, 429503

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
29300-128-01Hydrochlorothiazide100 in 1 BOTTLETABLET10012
29300-128-05Hydrochlorothiazide500 in 1 BOTTLETABLET50012
29300-128-10Hydrochlorothiazide1000 in 1 BOTTLETABLET100012
29300-128-50Hydrochlorothiazide5000 in 1 BOTTLETABLET500012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-128-01EA - Each29300-12846b95f4e-ca02-4085-a897-48ade8b7714212012-07-24
29300-128-10EA - Each29300-128763abd9d-027c-4267-9172-22e2e2195b8312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]5
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]5
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHYDROCHLOROTHIAZIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]5
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [DIRECT RX]3
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [DIRECT RX]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE TABLET [DIRECT RX]3
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHYDROCHLOROTHIAZIDE TABLET [DIRECT RX]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [DIRECT RX]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [DIRECT RX]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [DIRECT RX]3
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]2
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.]2
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHYDROCHLOROTHIAZIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-128HYDROCHLOROTHIAZIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]11Current NDC, Legacy NDC, 4 package rows20201014_33f3b980-b339-4dbf-99bd-05588c2a298c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310798hydroCHLOROthiazide 25 MG Oral TabletPSN96838fd0-ad87-4b45-b2c0-efdd1d2f3d1e17
310798hydrochlorothiazide 25 MG Oral TabletSCD96838fd0-ad87-4b45-b2c0-efdd1d2f3d1e17
310798HCTZ 25 MG Oral TabletSY96838fd0-ad87-4b45-b2c0-efdd1d2f3d1e17
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSN33f3b980-b339-4dbf-99bd-05588c2a298c12
310798hydroCHLOROthiazide 25 MG Oral TabletPSN33f3b980-b339-4dbf-99bd-05588c2a298c12
197770hydroCHLOROthiazide 50 MG Oral TabletPSN33f3b980-b339-4dbf-99bd-05588c2a298c12
429503hydrochlorothiazide 12.5 MG Oral TabletSCD33f3b980-b339-4dbf-99bd-05588c2a298c12
310798hydrochlorothiazide 25 MG Oral TabletSCD33f3b980-b339-4dbf-99bd-05588c2a298c12
197770hydrochlorothiazide 50 MG Oral TabletSCD33f3b980-b339-4dbf-99bd-05588c2a298c12
429503HCTZ 12.5 MG Oral TabletSY33f3b980-b339-4dbf-99bd-05588c2a298c12
310798HCTZ 25 MG Oral TabletSY33f3b980-b339-4dbf-99bd-05588c2a298c12
197770HCTZ 50 MG Oral TabletSY33f3b980-b339-4dbf-99bd-05588c2a298c12
310798hydroCHLOROthiazide 25 MG Oral TabletPSNf1f99065-04d2-48ac-b25d-9595237c869c11
310798hydrochlorothiazide 25 MG Oral TabletSCDf1f99065-04d2-48ac-b25d-9595237c869c11
310798HCTZ 25 MG Oral TabletSYf1f99065-04d2-48ac-b25d-9595237c869c11
310798hydroCHLOROthiazide 25 MG Oral TabletPSN73bc116a-2964-4acc-9ef0-0a3f662689139
310798hydrochlorothiazide 25 MG Oral TabletSCD73bc116a-2964-4acc-9ef0-0a3f662689139
310798HCTZ 25 MG Oral TabletSY73bc116a-2964-4acc-9ef0-0a3f662689139
310798hydroCHLOROthiazide 25 MG Oral TabletPSN088cb67f-3eaa-4e78-9fbe-ad2d6b7c57078
310798hydrochlorothiazide 25 MG Oral TabletSCD088cb67f-3eaa-4e78-9fbe-ad2d6b7c57078
310798HCTZ 25 MG Oral TabletSY088cb67f-3eaa-4e78-9fbe-ad2d6b7c57078
310798hydroCHLOROthiazide 25 MG Oral TabletPSN90a07625-214d-741f-e053-2a95a90a28327
310798hydroCHLOROthiazide 25 MG Oral TabletPSN9e6a0c83-1494-44ca-90e0-3f43fa8ec7467
310798hydrochlorothiazide 25 MG Oral TabletSCD90a07625-214d-741f-e053-2a95a90a28327
310798hydrochlorothiazide 25 MG Oral TabletSCD9e6a0c83-1494-44ca-90e0-3f43fa8ec7467
310798HCTZ 25 MG Oral TabletSY9e6a0c83-1494-44ca-90e0-3f43fa8ec7467
310798HCTZ 25 MG Oral TabletSY90a07625-214d-741f-e053-2a95a90a28327
310798hydroCHLOROthiazide 25 MG Oral TabletPSN2fd8f595-7aec-4308-bb17-a6f2e71900446
310798hydrochlorothiazide 25 MG Oral TabletSCD2fd8f595-7aec-4308-bb17-a6f2e71900446
310798HCTZ 25 MG Oral TabletSY2fd8f595-7aec-4308-bb17-a6f2e71900446
310798hydroCHLOROthiazide 25 MG Oral TabletPSN9cd5d16e-3db7-4b25-847d-6de91543463b5
310798hydrochlorothiazide 25 MG Oral TabletSCD9cd5d16e-3db7-4b25-847d-6de91543463b5
310798HCTZ 25 MG Oral TabletSY9cd5d16e-3db7-4b25-847d-6de91543463b5
310798hydroCHLOROthiazide 25 MG Oral TabletPSN99f45e08-897d-44dd-b48d-aa6d78981f0c4
310798hydroCHLOROthiazide 25 MG Oral TabletPSN8bc8d5e2-a974-64ed-e053-2a95a90a83404
310798hydrochlorothiazide 25 MG Oral TabletSCD99f45e08-897d-44dd-b48d-aa6d78981f0c4
310798hydrochlorothiazide 25 MG Oral TabletSCD8bc8d5e2-a974-64ed-e053-2a95a90a83404
310798HCTZ 25 MG Oral TabletSY99f45e08-897d-44dd-b48d-aa6d78981f0c4
310798HCTZ 25 MG Oral TabletSY8bc8d5e2-a974-64ed-e053-2a95a90a83404
310798hydroCHLOROthiazide 25 MG Oral TabletPSN5d56f7bc-96bd-47f4-8133-be7656f216c73
310798hydroCHLOROthiazide 25 MG Oral TabletPSN518be80a-9751-51b8-e054-00144ff88e883
310798hydroCHLOROthiazide 25 MG Oral TabletPSNff448eb4-b48f-46f5-ac30-f03aad08f9f53
310798hydrochlorothiazide 25 MG Oral TabletSCDff448eb4-b48f-46f5-ac30-f03aad08f9f53
310798hydrochlorothiazide 25 MG Oral TabletSCD5d56f7bc-96bd-47f4-8133-be7656f216c73
310798hydrochlorothiazide 25 MG Oral TabletSCD518be80a-9751-51b8-e054-00144ff88e883
310798HCTZ 25 MG Oral TabletSY5d56f7bc-96bd-47f4-8133-be7656f216c73
310798HCTZ 25 MG Oral TabletSY518be80a-9751-51b8-e054-00144ff88e883
310798HCTZ 25 MG Oral TabletSYff448eb4-b48f-46f5-ac30-f03aad08f9f53
310798hydroCHLOROthiazide 25 MG Oral TabletPSN8a1de4e2-3aca-a4d3-e053-2995a90a1a412
310798hydroCHLOROthiazide 25 MG Oral TabletPSNc1857e41-cf76-4cd1-914d-46332c1d69e62
310798hydroCHLOROthiazide 25 MG Oral TabletPSNfa1c0b92-4360-bcfd-e053-6394a90a955a2
310798hydrochlorothiazide 25 MG Oral TabletSCD8a1de4e2-3aca-a4d3-e053-2995a90a1a412
310798hydrochlorothiazide 25 MG Oral TabletSCDc1857e41-cf76-4cd1-914d-46332c1d69e62
310798hydrochlorothiazide 25 MG Oral TabletSCDfa1c0b92-4360-bcfd-e053-6394a90a955a2
310798HCTZ 25 MG Oral TabletSY8a1de4e2-3aca-a4d3-e053-2995a90a1a412
310798HCTZ 25 MG Oral TabletSYfa1c0b92-4360-bcfd-e053-6394a90a955a2
310798HCTZ 25 MG Oral TabletSYc1857e41-cf76-4cd1-914d-46332c1d69e62
310798hydroCHLOROthiazide 25 MG Oral TabletPSN2ec371a5-18ba-4ce2-9725-7f99bb73454a1
310798hydroCHLOROthiazide 25 MG Oral TabletPSN26a52b98-c383-b5e7-e063-6394a90ad6d31
310798hydrochlorothiazide 25 MG Oral TabletSCD2ec371a5-18ba-4ce2-9725-7f99bb73454a1
310798hydrochlorothiazide 25 MG Oral TabletSCD26a52b98-c383-b5e7-e063-6394a90ad6d31
310798HCTZ 25 MG Oral TabletSY26a52b98-c383-b5e7-e063-6394a90ad6d31
310798HCTZ 25 MG Oral TabletSY2ec371a5-18ba-4ce2-9725-7f99bb73454a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-128-0129300012801100 TABLET in 1 BOTTLE (29300-128-01) 100 tablet2009-07-020000-00-00NoNoCurrent
29300-128-0529300012805500 TABLET in 1 BOTTLE (29300-128-05) 500 tablet2009-07-020000-00-00NoNoCurrent
29300-128-10293000128101000 TABLET in 1 BOTTLE (29300-128-10) 1000 tablet2009-07-020000-00-00NoNoCurrent
29300-128-50293000128505000 TABLET in 1 BOTTLE (29300-128-50) 5000 tablet2009-07-020000-00-00NoNoCurrent