FDA.reportPublic FDA data

Hydrochlorothiazide

Product NDC
50228-146
11-digit product format
502280146
Labeler code
50228
Product ID
50228-146_6847f060-0180-4f7e-aba8-4dce8c53e7ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
ScieGen Pharmaceuticals Inc
Application
ANDA203561
Marketing category
ANDA
Marketing start
2019-01-14
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrochlorothiazide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH
Rxcui199903

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
50228-146-01Hydrochlorothiazide100 in 1 BOTTLECAPSULE1006
50228-146-05Hydrochlorothiazide500 in 1 BOTTLECAPSULE5006
50228-146-10Hydrochlorothiazide1000 in 1 BOTTLECAPSULE10006
50228-146-30Hydrochlorothiazide30 in 1 BOTTLECAPSULE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-146-01EA - Each50228-146a4d9dda4-60a9-489e-838a-d852c057a2aa12019-04-11
50228-146-05EA - Each50228-146b8192689-b5bc-4e0a-ada1-73b429b47f0f12019-04-11
50228-146-10EA - Each50228-1466b72885e-429f-4161-a323-599692e5a2fa12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-146HYDROCHLOROTHIAZIDE CAPSULE [SCIEGEN PHARMACEUTICALS INC]5Current NDC, Legacy NDC, 4 package rows20241109_911a18c1-120a-46b3-b7a8-25eb37843473.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN2b21f3fc-4164-401a-803e-b982dea97e19106
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD2b21f3fc-4164-401a-803e-b982dea97e19106
199903HCTZ 12.5 MG Oral CapsuleSY2b21f3fc-4164-401a-803e-b982dea97e19106
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSNff557069-f177-4e2e-91f4-675a033e2739103
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCDff557069-f177-4e2e-91f4-675a033e2739103
199903HCTZ 12.5 MG Oral CapsuleSYff557069-f177-4e2e-91f4-675a033e2739103
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN45316037-52ec-438f-8780-b2e983fef3f5101
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD45316037-52ec-438f-8780-b2e983fef3f5101
199903HCTZ 12.5 MG Oral CapsuleSY45316037-52ec-438f-8780-b2e983fef3f5101
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN0789baef-3424-43ab-a3fb-4908172da56513
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD0789baef-3424-43ab-a3fb-4908172da56513
199903HCTZ 12.5 MG Oral CapsuleSY0789baef-3424-43ab-a3fb-4908172da56513
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSNcb7b7315-0170-492c-803f-60a6e75e55da11
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCDcb7b7315-0170-492c-803f-60a6e75e55da11
199903HCTZ 12.5 MG Oral CapsuleSYcb7b7315-0170-492c-803f-60a6e75e55da11
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN918391e3-e8b3-4ceb-b4e7-c7c9617ea8827
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD918391e3-e8b3-4ceb-b4e7-c7c9617ea8827
199903HCTZ 12.5 MG Oral CapsuleSY918391e3-e8b3-4ceb-b4e7-c7c9617ea8827
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN02a481cb-ad80-41bb-82d3-c237b00ed8d76
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSNd6b933c6-f5f8-406a-84d6-b22c6040482a6
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN911a18c1-120a-46b3-b7a8-25eb378434736
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD911a18c1-120a-46b3-b7a8-25eb378434736
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD02a481cb-ad80-41bb-82d3-c237b00ed8d76
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCDd6b933c6-f5f8-406a-84d6-b22c6040482a6
199903HCTZ 12.5 MG Oral CapsuleSY02a481cb-ad80-41bb-82d3-c237b00ed8d76
199903HCTZ 12.5 MG Oral CapsuleSY911a18c1-120a-46b3-b7a8-25eb378434736
199903HCTZ 12.5 MG Oral CapsuleSYd6b933c6-f5f8-406a-84d6-b22c6040482a6
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSNf32ce8fe-6cbc-8a15-e053-2995a90a8eec4
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCDf32ce8fe-6cbc-8a15-e053-2995a90a8eec4
199903HCTZ 12.5 MG Oral CapsuleSYf32ce8fe-6cbc-8a15-e053-2995a90a8eec4
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN69c41abb-75f4-429b-905a-1ce967924aee1
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSNd9e27999-4ab8-7463-e053-2995a90a1dc41
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSNbd5728a2-6322-42e3-bd1e-e4915750e3981
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCDd9e27999-4ab8-7463-e053-2995a90a1dc41
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD69c41abb-75f4-429b-905a-1ce967924aee1
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCDbd5728a2-6322-42e3-bd1e-e4915750e3981
199903HCTZ 12.5 MG Oral CapsuleSY69c41abb-75f4-429b-905a-1ce967924aee1
199903HCTZ 12.5 MG Oral CapsuleSYbd5728a2-6322-42e3-bd1e-e4915750e3981
199903HCTZ 12.5 MG Oral CapsuleSYd9e27999-4ab8-7463-e053-2995a90a1dc41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-146-0150228014601100 CAPSULE in 1 BOTTLE (50228-146-01) 100 capsule2019-01-140000-00-00NoNoCurrent
50228-146-0550228014605500 CAPSULE in 1 BOTTLE (50228-146-05) 500 capsule2019-01-140000-00-00NoNoCurrent
50228-146-10502280146101000 CAPSULE in 1 BOTTLE (50228-146-10) 1000 capsule2019-01-140000-00-00NoNoCurrent
50228-146-305022801463030 CAPSULE in 1 BOTTLE (50228-146-30) 30 capsule2019-01-140000-00-00NoNoCurrent