Telmisartan and Hydrochlorothiazide

Product NDC
63629-7854
11-digit product format
636297854
Labeler code
63629
Product ID
63629-7854_c0dd30f3-6c48-455c-a701-72ddeeec93da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203010
Marketing category
ANDA
Marketing start
2016-06-25
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; TELMISARTAN
Active strength
13 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7854-12020-10-12C16284748780-19d75b9d0-9937-f424-e053-dadaa90a57cec0dd30f3-6c48-455c-a701-72ddeeec93da
63629-7854-12020-01-31C16284748780-19d75b9d0-9937-f424-e053-dadaa90a57cec0dd30f3-6c48-455c-a701-72ddeeec93da

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7854-16362978540130 TABLET in 1 BOTTLE (63629-7854-1) 30 tablet2021-12-230000-00-00NoNoCurrent