Sular

Product NDC
70515-501
11-digit product format
705150501
Labeler code
70515
Product ID
70515-501_daa4568e-f725-4df3-85eb-ff0ede789c78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nisoldipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Covis Pharma US, Inc
Application
NDA020356
Marketing category
NDA
Marketing start
2017-02-03
Substance
NISOLDIPINE
Active strength
17 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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N020356-001SULARNISOLDIPINE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-02
N020356-002SULARNISOLDIPINE20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-02
N020356-003SULARNISOLDIPINE30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-02
N020356-004SULARNISOLDIPINE40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1995-02-02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N020356-006SULARNISOLDIPINE25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2008-01-02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.

Additional Listing Data#

Finished product
Yes
Brand name base
Sular
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NISOLDIPINE17 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4I8HAB65SZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
763519Internal RxNorm lookup
763521Internal RxNorm lookup
763589Internal RxNorm lookup
763591Internal RxNorm lookup
790489Internal RxNorm lookup
790840Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
589157fa-d129-4de3-be3d-e0e1c22c5873Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e04fa8b-4f0f-e220-dece-f7d74308b047Product name220200505
63cce84a-c151-e237-b0c1-b5e9928f1ca7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70515-501-10Sular1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE16
70515-501-10Sular100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70515-501-10EA - Each70515-5012dc061a4-dbd0-4a9d-8430-7752b95bf14612017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70515-501SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [COVIS PHARMA US, INC]5Current NDC, Legacy NDC, 2 package rows20230207_589157fa-d129-4de3-be3d-e0e1c22c5873.zip

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
ndc (product): 70515-501
NisoldipineNISOLDIPINEPrasco Laboratories8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb2021-10-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020356
application number: NDA020356

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763519nisoldipine 17 MG 24HR Extended Release Oral TabletPSN589157fa-d129-4de3-be3d-e0e1c22c58736
763589nisoldipine 34 MG 24HR Extended Release Oral TabletPSN589157fa-d129-4de3-be3d-e0e1c22c58736
790489nisoldipine 8.5 MG 24HR Extended Release Oral TabletPSN589157fa-d129-4de3-be3d-e0e1c22c58736
763521Sular 17 MG 24HR Extended Release Oral TabletPSN589157fa-d129-4de3-be3d-e0e1c22c58736
763591Sular 34 MG 24HR Extended Release Oral TabletPSN589157fa-d129-4de3-be3d-e0e1c22c58736
790840Sular 8.5 MG 24HR Extended Release Oral TabletPSN589157fa-d129-4de3-be3d-e0e1c22c58736
76352124 HR nisoldipine 17 MG Extended Release Oral Tablet [Sular]SBD589157fa-d129-4de3-be3d-e0e1c22c58736
76359124 HR nisoldipine 34 MG Extended Release Oral Tablet [Sular]SBD589157fa-d129-4de3-be3d-e0e1c22c58736
79084024 HR nisoldipine 8.5 MG Extended Release Oral Tablet [Sular]SBD589157fa-d129-4de3-be3d-e0e1c22c58736
76351924 HR nisoldipine 17 MG Extended Release Oral TabletSCD589157fa-d129-4de3-be3d-e0e1c22c58736
76358924 HR nisoldipine 34 MG Extended Release Oral TabletSCD589157fa-d129-4de3-be3d-e0e1c22c58736
79048924 HR nisoldipine 8.5 MG Extended Release Oral TabletSCD589157fa-d129-4de3-be3d-e0e1c22c58736
76352124 HR Sular 17 MG Extended Release Oral TabletSY589157fa-d129-4de3-be3d-e0e1c22c58736
76359124 HR Sular 34 MG Extended Release Oral TabletSY589157fa-d129-4de3-be3d-e0e1c22c58736
79084024 HR Sular 8.5 MG Extended Release Oral TabletSY589157fa-d129-4de3-be3d-e0e1c22c58736
763519nisoldipine 17 MG 24 HR Extended Release Oral TabletSY589157fa-d129-4de3-be3d-e0e1c22c58736
763589nisoldipine 34 MG 24 HR Extended Release Oral TabletSY589157fa-d129-4de3-be3d-e0e1c22c58736
790489nisoldipine 8.5 MG 24 HR Extended Release Oral TabletSY589157fa-d129-4de3-be3d-e0e1c22c58736
763521Sular 17 MG 24 HR Extended Release Oral TabletSY589157fa-d129-4de3-be3d-e0e1c22c58736
763591Sular 34 MG 24 HR Extended Release Oral TabletSY589157fa-d129-4de3-be3d-e0e1c22c58736
790840Sular 8.5 MG 24 HR Extended Release Oral TabletSY589157fa-d129-4de3-be3d-e0e1c22c58736

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70515-501-10705150501101 BOTTLE in 1 CARTON (70515-501-10) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-02-030000-00-00NoNoCurrent