ASPRUZYO SPRINKLE

Product NDC
47335-625
11-digit product format
473350625
Labeler code
47335
Product ID
47335-625_2cd273e4-313f-3562-e063-6394a90ac135
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
GRANULE
Route
ORAL
Labeler
SUN PHARMACEUTICAL INDUSTRIES, INC.
Application
NDA216018
Marketing category
NDA
Marketing start
2022-02-28
Substance
RANOLAZINE
Active strength
1000 mg/1
Pharmacologic classes
Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N216018-001ASPRUZYO SPRINKLERANOLAZINE500MGGRANULE, EXTENDED RELEASE / ORALRLD2022-02-28
N216018-002ASPRUZYO SPRINKLERANOLAZINE1GMGRANULE, EXTENDED RELEASE / ORALRLD2022-02-28

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N216018-001115108782038-01-24Drug product2022-12-01
N216018-002108984442038-01-24Drug product2022-03-03
N216018-002115108782038-01-24Drug product2022-12-01
N216018-002121617612038-01-24Drug product2024-12-19

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 2 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N216018-001ASPRUZYO SPRINKLE500MGGRANULE, EXTENDED RELEASE / ORALRLD2022-02-28caaa826d4ba7…
2026-08-18 06:07:402026-07N216018-002ASPRUZYO SPRINKLE1GMGRANULE, EXTENDED RELEASE / ORALRLD2022-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD2022-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD2022-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD2022-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD2022-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD2022-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD2022-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD2022-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD2022-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD2022-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD2022-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD, RS2022-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD, RS2022-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD, RS2022-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD, RS2022-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD, RS2022-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD, RS2022-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD, RS2022-02-284b0b4de00fa7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-286a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD, RS2022-02-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N216018-001ASPRUZYO SPRINKLE500MGGRANULES, EXTENDED RELEASE / ORALRLD2022-02-281c564ffb4f44…
2024-02-18 07:12 UTC2024-02N216018-002ASPRUZYO SPRINKLE1GMGRANULES, EXTENDED RELEASE / ORALRLD, RS2022-02-281c564ffb4f44…

Observed Orange Book patent history#

Patent history page 1 of 3 · 89 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N216018-001115108782038-01-24Drug product2022-12-01caaa826d4ba7…
2026-08-18 06:07:402026-07N216018-002108984442038-01-24Drug product2022-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07N216018-002115108782038-01-24Drug product2022-12-01caaa826d4ba7…
2026-08-18 06:07:402026-07N216018-002121617612038-01-24Drug product2024-12-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216018-001115108782038-01-24Drug product2022-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216018-002108984442038-01-24Drug product2022-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216018-002115108782038-01-24Drug product2022-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216018-002121617612038-01-24Drug product2024-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216018-001115108782038-01-24Drug product2022-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216018-002108984442038-01-24Drug product2022-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216018-002115108782038-01-24Drug product2022-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216018-002121617612038-01-24Drug product2024-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N216018-001115108782038-01-24Drug product2022-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216018-002108984442038-01-24Drug product2022-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216018-002115108782038-01-24Drug product2022-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216018-002121617612038-01-24Drug product2024-12-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216018-001115108782038-01-24Drug product2022-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216018-002108984442038-01-24Drug product2022-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216018-002115108782038-01-24Drug product2022-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216018-002121617612038-01-24Drug product2024-12-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216018-001115108782038-01-24Drug product2022-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216018-002108984442038-01-24Drug product2022-03-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216018-002115108782038-01-24Drug product2022-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216018-002121617612038-01-24Drug product2024-12-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216018-001115108782038-01-24Drug product2022-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216018-002108984442038-01-24Drug product2022-03-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216018-002115108782038-01-24Drug product2022-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216018-002121617612038-01-24Drug product2024-12-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216018-001115108782038-01-24Drug product2022-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216018-002108984442038-01-24Drug product2022-03-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216018-002115108782038-01-24Drug product2022-12-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216018-001115108782038-01-24Drug product2022-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216018-002108984442038-01-24Drug product2022-03-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N216018-002115108782038-01-24Drug product2022-12-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216018-001115108782038-01-24Drug product2022-12-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216018-002108984442038-01-24Drug product2022-03-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216018-002115108782038-01-24Drug product2022-12-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N216018-001115108782038-01-24Drug product2022-12-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N216018-002108984442038-01-24Drug product2022-03-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N216018-002115108782038-01-24Drug product2022-12-01d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
ASPRUZYO SPRINKLE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANOLAZINE1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
A6IEZ5M406Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2594753Internal RxNorm lookup
2594759Internal RxNorm lookup
2594760Internal RxNorm lookup
2594762Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dd9f81e4-50da-4551-aed5-559d304df42eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4367aed1-e488-b72c-d0ec-178a4e054129Product name920250624
ddc83a74-720a-4975-8550-c4bd979c9094Product name120221212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-625-11ASPRUZYO SPRINKLE1 in 1 PACKETGRANULE13
47335-625-30ASPRUZYO SPRINKLE30 in 1 CARTONGRANULE303
47335-625-60ASPRUZYO SPRINKLE60 in 1 CARTONGRANULE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-625-11EA - Each47335-6258e876d3d-3af4-4be1-b455-8d5d1892ead812022-08-04
47335-625-60EA - Each47335-62545c66337-5ebd-4ada-8dd3-3b9b94222aa712022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-625ASPRUZYO SPRINKLE (RANOLAZINE) GRANULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]3Current NDC, Legacy NDC, 3 package rows20250130_dd9f81e4-50da-4551-aed5-559d304df42e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ASPRUZYO SPRINKLERANOLAZINESUN PHARMACEUTICAL INDUSTRIES, INC.dd9f81e4-50da-4551-aed5-559d304df42e2025-01-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 216018
application number: NDA216018
ndc (product): 47335-625

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2594759ASPRUZYO Sprinkle 1000 MG Oral GranulesPSNdd9f81e4-50da-4551-aed5-559d304df42e3
2594762ASPRUZYO Sprinkle 500 MG Oral GranulesPSNdd9f81e4-50da-4551-aed5-559d304df42e3
2594753ranolazine 1000 MG Oral GranulesPSNdd9f81e4-50da-4551-aed5-559d304df42e3
2594760ranolazine 500 MG Oral GranulesPSNdd9f81e4-50da-4551-aed5-559d304df42e3
2594759ranolazine 1000 MG Oral Granules [Aspruzyo]SBDdd9f81e4-50da-4551-aed5-559d304df42e3
2594762ranolazine 500 MG Oral Granules [Aspruzyo]SBDdd9f81e4-50da-4551-aed5-559d304df42e3
2594753ranolazine 1000 MG Oral GranulesSCDdd9f81e4-50da-4551-aed5-559d304df42e3
2594760ranolazine 500 MG Oral GranulesSCDdd9f81e4-50da-4551-aed5-559d304df42e3
2594759Aspruzyo 1000 MG Oral GranulesSYdd9f81e4-50da-4551-aed5-559d304df42e3
2594762Aspruzyo 500 MG Oral GranulesSYdd9f81e4-50da-4551-aed5-559d304df42e3
2594759Aspruzyo Sprinkle 1 GM Oral GranulesSYdd9f81e4-50da-4551-aed5-559d304df42e3
2594759Aspruzyo Sprinkle 1000 MG Oral GranulesSYdd9f81e4-50da-4551-aed5-559d304df42e3
2594762Aspruzyo Sprinkle 500 MG Oral GranulesSYdd9f81e4-50da-4551-aed5-559d304df42e3
2594753ranolazine 1 GM Oral GranulesSYdd9f81e4-50da-4551-aed5-559d304df42e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-625-11473350625111 GRANULE in 1 PACKET (47335-625-11) 1 granule2022-02-280000-00-00NoNoCurrent
47335-625-304733506253030 GRANULE in 1 CARTON (47335-625-30) 30 granule2022-02-280000-00-00NoNoCurrent
47335-625-604733506256060 GRANULE in 1 CARTON (47335-625-60) 60 granule2022-02-280000-00-00NoNoCurrent