FDA.reportPublic FDA data

Hydrochlorothiazide

Product NDC
23155-045
11-digit product format
231550045
Labeler code
23155
Product ID
23155-045_cc337e65-addc-42f4-b19b-fd5c8ebcca41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc.
Application
ANDA079237
Marketing category
ANDA
Marketing start
2010-12-10
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE
Active strength
13 mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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
23155-045-012020-08-07C16284748780-19d75b9d0-c3c4-f424-e053-dadaa90a57ceb8a7f534-eb19-4aa1-8730-d3ecf3cefb01
23155-045-032020-08-07C16284748780-19d75b9d0-c3c4-f424-e053-dadaa90a57ceb8a7f534-eb19-4aa1-8730-d3ecf3cefb01
23155-045-052020-08-07C16284748780-19d75b9d0-c3c4-f424-e053-dadaa90a57ceb8a7f534-eb19-4aa1-8730-d3ecf3cefb01
23155-045-102020-08-07C16284748780-19d75b9d0-c3c4-f424-e053-dadaa90a57ceb8a7f534-eb19-4aa1-8730-d3ecf3cefb01
23155-045-012020-01-31C16284748780-19d75b9d0-c3c4-f424-e053-dadaa90a57ceb8a7f534-eb19-4aa1-8730-d3ecf3cefb01
23155-045-032020-01-31C16284748780-19d75b9d0-c3c4-f424-e053-dadaa90a57ceb8a7f534-eb19-4aa1-8730-d3ecf3cefb01
23155-045-052020-01-31C16284748780-19d75b9d0-c3c4-f424-e053-dadaa90a57ceb8a7f534-eb19-4aa1-8730-d3ecf3cefb01
23155-045-102020-01-31C16284748780-19d75b9d0-c3c4-f424-e053-dadaa90a57ceb8a7f534-eb19-4aa1-8730-d3ecf3cefb01

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-045-01EA - Each23155-0458fe35bb6-1814-418d-9e3a-5d514b633fbf12012-07-24
23155-045-05EA - Each23155-045f717828b-14ff-4f30-9ca6-885ab3db8e0b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE [TYA PHARMACEUTICALS]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE [TYA PHARMACEUTICALS]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROCHLOROTHIAZIDE CAPSULE [TYA PHARMACEUTICALS]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE CAPSULE [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE CAPSULE [TYA PHARMACEUTICALS]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE [TYA PHARMACEUTICALS]2
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE [TYA PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE CAPSULE [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCHLOROTHIAZIDE CAPSULE [TYA PHARMACEUTICALS]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROCHLOROTHIAZIDE CAPSULE [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE [TYA PHARMACEUTICALS]2
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN999116d1-7e33-4b7c-adef-39f067b401922
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD999116d1-7e33-4b7c-adef-39f067b401922
199903HCTZ 12.5 MG Oral CapsuleSY999116d1-7e33-4b7c-adef-39f067b401922
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN209b1202-c3a8-4f2b-93c6-60fe37a2011f1
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD209b1202-c3a8-4f2b-93c6-60fe37a2011f1
199903HCTZ 12.5 MG Oral CapsuleSY209b1202-c3a8-4f2b-93c6-60fe37a2011f1