FDA.reportPublic FDA data

Hydrochlorothiazide

Product NDC
67046-278
11-digit product format
670460278
Labeler code
67046
Product ID
67046-278_7d7699fe-a10e-cac2-e053-2991aa0a9e76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA202556
Marketing category
ANDA
Marketing start
2017-09-28
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE
Active strength
25 mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
67046-278-072022-01-28C16284748780-1d6a99b39-d162-a426-e053-dadaa90af4c2278 HCTZ 25 mg HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
67046-278-142022-01-28C16284748780-1d6a99b39-d162-a426-e053-dadaa90af4c2278 HCTZ 25 mg HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
67046-278-152022-01-28C16284748780-1d6a99b39-d162-a426-e053-dadaa90af4c2278 HCTZ 25 mg HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
67046-278-202022-01-28C16284748780-1d6a99b39-d162-a426-e053-dadaa90af4c2278 HCTZ 25 mg HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
67046-278-212022-01-28C16284748780-1d6a99b39-d162-a426-e053-dadaa90af4c2278 HCTZ 25 mg HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
67046-278-282022-01-28C16284748780-1d6a99b39-d162-a426-e053-dadaa90af4c2278 HCTZ 25 mg HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
67046-278-302022-01-28C16284748780-1d6a99b39-d162-a426-e053-dadaa90af4c2278 HCTZ 25 mg HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
67046-278-602022-01-28C16284748780-1d6a99b39-d162-a426-e053-dadaa90af4c2278 HCTZ 25 mg HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-278-07Hydrochlorothiazide7 in 1 BLISTER PACKTABLET72
67046-278-14Hydrochlorothiazide14 in 1 BLISTER PACKTABLET142
67046-278-15Hydrochlorothiazide15 in 1 BLISTER PACKTABLET152
67046-278-20Hydrochlorothiazide20 in 1 BLISTER PACKTABLET202
67046-278-21Hydrochlorothiazide21 in 1 BLISTER PACKTABLET212
67046-278-28Hydrochlorothiazide28 in 1 BLISTER PACKTABLET282
67046-278-30Hydrochlorothiazide30 in 1 BLISTER PACKTABLET302
67046-278-60Hydrochlorothiazide60 in 1 BLISTER PACKTABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-278HYDROCHLOROTHIAZIDE TABLET [CONTRACT PHARMACY SERVICES-PA]2Legacy NDC, 8 package rows20181221_5a431eed-b974-701a-e053-2991aa0aa6ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310798hydroCHLOROthiazide 25 MG Oral TabletPSN5a431eed-b974-701a-e053-2991aa0aa6ee2
310798hydrochlorothiazide 25 MG Oral TabletSCD5a431eed-b974-701a-e053-2991aa0aa6ee2
310798HCTZ 25 MG Oral TabletSY5a431eed-b974-701a-e053-2991aa0aa6ee2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-278-07670460278077 TABLET in 1 BLISTER PACK (67046-278-07) 7 tablet2017-09-280000-00-00NoNoCurrent
67046-278-146704602781414 TABLET in 1 BLISTER PACK (67046-278-14) 14 tablet2017-09-280000-00-00NoNoCurrent
67046-278-156704602781515 TABLET in 1 BLISTER PACK (67046-278-15) 15 tablet2017-09-280000-00-00NoNoCurrent
67046-278-206704602782020 TABLET in 1 BLISTER PACK (67046-278-20) 20 tablet2017-09-280000-00-00NoNoCurrent
67046-278-216704602782121 TABLET in 1 BLISTER PACK (67046-278-21) 21 tablet2017-09-280000-00-00NoNoCurrent
67046-278-286704602782828 TABLET in 1 BLISTER PACK (67046-278-28) 28 tablet2017-09-280000-00-00NoNoCurrent
67046-278-306704602783030 TABLET in 1 BLISTER PACK (67046-278-30) 30 tablet2017-09-280000-00-00NoNoCurrent
67046-278-606704602786060 TABLET in 1 BLISTER PACK (67046-278-60) 60 tablet2017-09-280000-00-00NoNoCurrent