FDA.reportPublic FDA data

NDC 63629-1092-01 - SPIRONOLACTONE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63629-1092
Requested NDC
63629-1092-01
Package NDCs from labels
63629-1092-1, 63629-1092-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-08-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SPIRONOLACTONE - Bryant Ranch PrepackBryant Ranch Prepack2024-08-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1092-1SPIRONOLACTONE100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1092SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]21Current NDC, Legacy NDC, 1 package rows20240806_1fe93db1-0012-4ff6-a4e6-04e2d7e9f638.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1092-1EA - Each63629-109206169711-9c05-417b-a5de-0988a668226e12020-09-14

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 162 · 3,221 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener Extra StrengthDOCUSATE SODIUMP & L Development, LLC4e97dd60-96e3-4b51-b614-c62480af19192026-08-06WarningsExact identifier
unii: F05Q2T2JA0
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLC098d2377-0019-45fe-b995-700b1b1241c42026-08-05WarningsExact identifier
unii: F05Q2T2JA0
Docusate Sodium softgels 50mg (Dye Free)DOCUSATE SODIUMCVS Pharmacy273ea95f-3c9c-98e8-e063-6294a90a21352026-08-05WarningsExact identifier
unii: F05Q2T2JA0
MiraSOFT Stool SoftenerDOCUSATE SODIUMBayer HealthCare LLC.5851f15f-8add-559f-e063-6394a90a7b7d2026-08-05WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcbb0edf4-1fa7-42f5-a6f7-027e3961b50a2026-08-05WarningsExact identifier
unii: F05Q2T2JA0
Hypothalmu StimARALIA QUINQUEFOLIA, GINKGO BILOBA, HYDROCOTYLE ASIATICA, BRAIN, HYPOTHALAMUS, PITUITARY, PHOSPHORUSThe Wise Alternative00d8c4da-3bf2-41f9-b6db-891078a69d072026-08-05WarningsExact identifier
unii: ETJ7Z6XBU4
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
spironolactoneSPIRONOLACTONEREMEDYREPACK INC.8b76a904-6c99-485a-a05f-13a36c5f720c2026-08-04Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.7793fced-e8ee-44e2-b212-dd2a59a5f4622026-08-04WarningsExact identifier
unii: F05Q2T2JA0
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Dual Action Senna Stool SoftenerDOCUSATE SODIUM 50 MG, SENNOSIDES 8.6 MGShield Pharmaceuticals Corpa04435df-aace-497f-a3a8-d8e8489db6612026-08-03WarningsExact identifier
unii: F05Q2T2JA0
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
SPIRONOLACTONESPIRONOLACTONESun Pharmaceutical Industries, Inc.c23b6b9b-aec3-48a8-a518-76e4097f64792026-07-31Warnings, Adverse reactionsExact identifier
application number: ANDA089424
ndc (product): 53489-329
rxcui: 198222
rxcui: 313096
rxcui: 198223
spl id: 57e3eb73-8cac-c76d-e063-6394a90a5962
spl set id: c23b6b9b-aec3-48a8-a518-76e4097f6479
unii: 27O7W4T232
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
HCG FormulaFOENICULUM VULGARE, FUCUS VESICULOSUS, LECITHIN, AMMONIUM CARBONICUM, CAULOPHYLLUM THALICTROIDES, GALIUM APARINE, LAC DEFLORATUM, PHOSPHORUS, PHYTOLACCA DECANDRA, RUBUS IDAEUS, ABROTANUM,Apotheca Company9bf57bf0-6574-4f6d-99f3-0b0f505033572026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4