SPIRONOLACTONE

Product NDC
16714-086
11-digit product format
167140086
Labeler code
16714
Product ID
16714-086_192faced-01bc-42a8-ad1f-492d6c3108f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SPIRONOLACTONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA089424
Marketing category
ANDA
Marketing start
2020-04-23
Marketing end
0000-00-00
Substance
SPIRONOLACTONE
Active strength
100 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d335cba1-5b36-51c8-120a-594ec9d05330Product name520251114
25f5e2cf-3572-477b-994c-aa692751e5a8Product name220250616
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-086-01EA - Each16714-086bb41d7f8-2c0a-4522-8afb-027c9e5d556f12020-09-14
16714-086-02EA - Each16714-08616453476-8683-46ea-a02c-5796e905638c12020-09-14
16714-086-03EA - Each16714-0865954138d-6974-4660-9a27-786510ba2ad012020-09-14
16714-086-04EA - Each16714-08685cfe36d-cab8-4b93-b0b6-5ee3442854ec12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-086SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [NORTHSTAR RX LLC]5Legacy NDC20240802_2aead427-3e25-4a87-a858-f2bd7642baf5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSNf98e8ce9-4dbf-2740-e053-6394a90a5ddb1
198222spironolactone 100 MG Oral TabletSCDf98e8ce9-4dbf-2740-e053-6394a90a5ddb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-086-011671400860130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-086-01) 2020-04-230000-00-00NoNoCurrent
16714-086-021671400860260 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-086-02) 2020-04-230000-00-00NoNoCurrent
16714-086-0316714008603100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-086-03) 2020-04-230000-00-00NoNoCurrent
16714-086-0416714008604500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-086-04) 2020-04-230000-00-00NoNoCurrent