FDA.reportPublic FDA data

hydrochlorothiazide

Product NDC
46708-438
11-digit product format
467080438
Labeler code
46708
Product ID
46708-438_8ed60738-80b1-4c2d-a0f1-cf5fa17f8308
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA200645
Marketing category
ANDA
Marketing start
2017-03-02
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

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 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46708-438-102023-02-01C16284748780-1f386c649-b12f-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-302023-02-01C16284748780-1f386c649-b12f-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-312023-02-01C16284748780-1f386c649-b12f-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-712023-02-01C16284748780-1f386c649-b12f-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-912023-02-01C16284748780-1f386c649-b12f-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-102023-01-30C16284748780-1f386c649-b12f-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-302023-01-30C16284748780-1f386c649-b12f-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-312023-01-30C16284748780-1f386c649-b12f-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-712023-01-30C16284748780-1f386c649-b12f-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-912023-01-30C16284748780-1f386c649-b12f-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP, 12.5 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-438-10hydrochlorothiazide10 in 1 BLISTER PACKCAPSULE103
46708-438-10hydrochlorothiazide10 in 1 CARTONCAPSULE103
46708-438-30hydrochlorothiazide30 in 1 BOTTLECAPSULE303
46708-438-31hydrochlorothiazide100 in 1 BOTTLECAPSULE1003
46708-438-71hydrochlorothiazide500 in 1 BOTTLECAPSULE5003
46708-438-91hydrochlorothiazide1000 in 1 BOTTLECAPSULE10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-438HYDROCHLOROTHIAZIDE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 6 package rows20230202_34703033-14c4-459c-8b8f-2f2e1145aff7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN34703033-14c4-459c-8b8f-2f2e1145aff73
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD34703033-14c4-459c-8b8f-2f2e1145aff73
199903HCTZ 12.5 MG Oral CapsuleSY34703033-14c4-459c-8b8f-2f2e1145aff73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-438-104670804381010 BLISTER PACK in 1 CARTON (46708-438-10) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2017-03-020000-00-00NoNoCurrent
46708-438-304670804383030 CAPSULE in 1 BOTTLE (46708-438-30) 30 capsule2017-03-020000-00-00NoNoCurrent
46708-438-3146708043831100 CAPSULE in 1 BOTTLE (46708-438-31) 100 capsule2017-03-020000-00-00NoNoCurrent
46708-438-7146708043871500 CAPSULE in 1 BOTTLE (46708-438-71) 500 capsule2017-03-020000-00-00NoNoCurrent
46708-438-91467080438911000 CAPSULE in 1 BOTTLE (46708-438-91) 1000 capsule2017-03-020000-00-00NoNoCurrent