SULAR

Product NDC
59630-500
11-digit product format
596300500
Labeler code
59630
Product ID
59630-500_afb5a339-f18f-4850-8041-24859b814174
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nisoldipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Shionogi Inc.
Application
NDA020356
Marketing category
NDA
Marketing start
1995-02-02
Marketing end
0000-00-00
Substance
NISOLDIPINE
Active strength
9 mg/1
Pharmacologic classes
Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59630-500DDiscontinued by firm2026-10-05
excluded packagepackage59630-50059630-500-10DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59630-500-10DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59630-500-10DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59630-500-10DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59630-500-10DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59630-500-10DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59630-500-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59630-500-10DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59630-500-10DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59630-500-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59630-500-10DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59630-500-10DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59630-500-10DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59630-500-10EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020356-001SULARNISOLDIPINE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-02
N020356-002SULARNISOLDIPINE20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-02
N020356-003SULARNISOLDIPINE30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-02
N020356-004SULARNISOLDIPINE40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-02
N020356-005SULARNISOLDIPINE34MGTABLET, EXTENDED RELEASE / ORALRLD2008-01-02
N020356-006SULARNISOLDIPINE25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2008-01-02
N020356-007SULARNISOLDIPINE17MGTABLET, EXTENDED RELEASE / ORALRLD2008-01-02
N020356-008SULARNISOLDIPINE8.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2008-01-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N020356-008AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 9 · 344 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020356-001SULAR10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-0284e616aacf4f…
2026-09-14 22:38:342026-08N020356-002SULAR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-0284e616aacf4f…
2026-09-14 22:38:342026-08N020356-003SULAR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-0284e616aacf4f…
2026-09-14 22:38:342026-08N020356-004SULAR40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-0284e616aacf4f…
2026-09-14 22:38:342026-08N020356-005SULAR34MGTABLET, EXTENDED RELEASE / ORALRLD2008-01-0284e616aacf4f…
2026-09-14 22:38:342026-08N020356-006SULAR25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2008-01-0284e616aacf4f…
2026-09-14 22:38:342026-08N020356-007SULAR17MGTABLET, EXTENDED RELEASE / ORALRLD2008-01-0284e616aacf4f…
2026-09-14 22:38:342026-08N020356-008SULAR8.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2008-01-0284e616aacf4f…
2026-08-18 06:07:402026-07N020356-001SULAR10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07N020356-002SULAR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07N020356-003SULAR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07N020356-004SULAR40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07N020356-005SULAR34MGTABLET, EXTENDED RELEASE / ORALRLD2008-01-02caaa826d4ba7…
2026-08-18 06:07:402026-07N020356-006SULAR25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2008-01-02caaa826d4ba7…
2026-08-18 06:07:402026-07N020356-007SULAR17MGTABLET, EXTENDED RELEASE / ORALRLD2008-01-02caaa826d4ba7…
2026-08-18 06:07:402026-07N020356-008SULAR8.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2008-01-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020356-001SULAR10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020356-002SULAR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020356-003SULAR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020356-004SULAR40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020356-005SULAR34MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2008-01-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020356-006SULAR25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2008-01-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020356-007SULAR17MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2008-01-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020356-008SULAR8.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2008-01-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020356-001SULAR10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020356-002SULAR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020356-003SULAR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020356-004SULAR40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020356-005SULAR34MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2008-01-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020356-006SULAR25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2008-01-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020356-007SULAR17MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2008-01-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020356-008SULAR8.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2008-01-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N020356-001SULAR10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020356-002SULAR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020356-003SULAR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020356-004SULAR40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020356-005SULAR34MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2008-01-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020356-006SULAR25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2008-01-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020356-007SULAR17MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2008-01-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020356-008SULAR8.5MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2008-01-026a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N020356-008AB184e616aacf4f…
2026-08-18 06:07:402026-07N020356-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020356-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020356-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020356-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020356-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020356-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020356-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020356-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020356-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020356-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020356-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020356-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020356-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020356-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020356-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020356-008AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020356-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020356-007AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020356-008AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020356-005AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020356-007AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020356-008AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020356-005AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020356-007AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020356-008AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020356-005AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020356-007AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020356-008AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020356-005AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020356-007AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020356-008AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020356-005AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020356-007AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020356-008AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020356-005AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020356-007AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020356-008AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020356-005AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020356-007AB11e350fbaab3a…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59630-500-10EA - Each59630-50022d5bf1c-eea6-4f98-b669-ea49e9f014a012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NISOLDIPINEACTIVE INGREDIENT4I8HAB65SZSULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]9
NISOLDIPINEACTIVE MOIETY4I8HAB65SZSULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]9
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]9
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MSULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]9
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]9
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRSULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]9
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]9
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)INACTIVE INGREDIENT5KY68S2577SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]9
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]9
POVIDONESINACTIVE INGREDIENTFZ989GH94ESULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]9

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SularNISOLDIPINECovis Pharma US, Inc589157fa-d129-4de3-be3d-e0e1c22c58732026-03-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 020356
application number: NDA020356
NisoldipineNISOLDIPINEPrasco Laboratories8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb2021-10-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020356
application number: NDA020356