Rosuvastatin Calcium

Product NDC
72603-365
11-digit product format
726030365
Labeler code
72603
Product ID
72603-365_4687569b-7762-fb06-e063-6294a90aadc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar Rx, LLC
Application
ANDA207626
Marketing category
ANDA
Marketing start
2025-12-15
Substance
ROSUVASTATIN CALCIUM
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase 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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207626-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-04-09
A207626-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-04-09
A207626-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-04-09
A207626-004ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-04-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A207626-001AB
A207626-002AB
A207626-003AB
A207626-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207626-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207626-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207626-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207626-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-04-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207626-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207626-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207626-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207626-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-04-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207626-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207626-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207626-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207626-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-04-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207626-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207626-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207626-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207626-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-04-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207626-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207626-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207626-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207626-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-04-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207626-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207626-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207626-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207626-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-04-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207626-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207626-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207626-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207626-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-04-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207626-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-04-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207626-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-04-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207626-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-04-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207626-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-04-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207626-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-04-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207626-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-04-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207626-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-04-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207626-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-04-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207626-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-04-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A207626-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-04-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A207626-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-04-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A207626-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-04-09d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207626-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207626-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207626-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207626-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207626-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207626-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207626-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207626-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207626-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207626-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207626-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207626-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207626-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207626-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207626-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207626-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207626-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207626-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207626-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207626-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207626-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207626-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207626-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207626-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207626-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207626-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207626-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207626-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207626-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207626-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207626-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207626-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207626-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207626-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207626-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207626-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207626-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207626-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207626-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207626-004AB1d06236e962d9…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rosuvastatin CalciumROSUVASTATIN CALCIUMREMEDYREPACK INC.0c919fc0-a3d7-4afb-968b-4ef0e447001c2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207626
application number: ANDA207626
Rosuvastatin CalciumROSUVASTATIN CALCIUMNorthStar Rx, LLCc622757d-7370-438b-8c2d-ef444a4f31dd2026-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207626
application number: ANDA207626
ndc (product): 72603-365
Rosuvastatin CalciumROSUVASTATIN CALCIUMUmedica Laboratories USA Inc.989dffcf-0254-439d-9f3f-3b0e9d32de0a2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207626
application number: ANDA207626
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutions9d5f8ff6-c622-4101-805d-70bdc888b27e2026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207626
application number: ANDA207626
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutions5da61cc3-93f3-4d95-ab39-55821484a3bd2026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207626
application number: ANDA207626
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutions2984f47e-9246-46d0-842e-43c540dd12a52026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207626
application number: ANDA207626
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutions2c72feef-6742-4d8a-9515-89be4e430c4f2026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207626
application number: ANDA207626
Rosuvastatin CalciumROSUVASTATIN CALCIUMPreferred Pharmaceuticals Inc.1346ab60-808b-442b-8217-a59bb9986f032026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207626
application number: ANDA207626
Rosuvastatin CalciumROSUVASTATIN CALCIUMPreferred Pharmaceuticals Inc.60d52228-f74f-46eb-85d2-e6b0cbb360922026-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207626
application number: ANDA207626
Rosuvastatin CalciumROSUVASTATIN CALCIUMTORRENT PHARMACEUTICALS LIMITED6985e729-d963-4f32-89a1-727472b86daa2025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207626
application number: ANDA207626
Rosuvastatin CalciumROSUVASTATIN CALCIUMPreferred Pharmaceuticals Inc.1eb971e3-de67-46ae-a8ef-8a7d2805cfdd2025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207626
application number: ANDA207626
Rosuvastatin CalciumROSUVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.20101145-4c4f-8f0a-e063-6394a90ae27d2024-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207626
application number: ANDA207626
Rosuvastatin CalciumROSUVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.1aca7a86-940b-c6e1-e063-6294a90a59442024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207626
application number: ANDA207626

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
83MVU38M7QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
859419Internal RxNorm lookup
859424Internal RxNorm lookup
859747Internal RxNorm lookup
859751Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c622757d-7370-438b-8c2d-ef444a4f31ddAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-365-01Rosuvastatin Calcium90 in 1 BOTTLETABLET902
72603-365-02Rosuvastatin Calcium1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-365-01EA - Each72603-36532e778be-5bc9-4d75-b056-1222d8025dd712026-03-17
72603-365-02EA - Each72603-365eccb206f-903f-4d1b-95db-f684941b489112026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSNc622757d-7370-438b-8c2d-ef444a4f31dd2
859751rosuvastatin calcium 20 MG Oral TabletPSNc622757d-7370-438b-8c2d-ef444a4f31dd2
859419rosuvastatin calcium 40 MG Oral TabletPSNc622757d-7370-438b-8c2d-ef444a4f31dd2
859424rosuvastatin calcium 5 MG Oral TabletPSNc622757d-7370-438b-8c2d-ef444a4f31dd2
859747rosuvastatin calcium 10 MG Oral TabletSCDc622757d-7370-438b-8c2d-ef444a4f31dd2
859751rosuvastatin calcium 20 MG Oral TabletSCDc622757d-7370-438b-8c2d-ef444a4f31dd2
859419rosuvastatin calcium 40 MG Oral TabletSCDc622757d-7370-438b-8c2d-ef444a4f31dd2
859424rosuvastatin calcium 5 MG Oral TabletSCDc622757d-7370-438b-8c2d-ef444a4f31dd2
859747rosuvastatin calcium 10 MG Oral TabletPSN2984f47e-9246-46d0-842e-43c540dd12a51
859747rosuvastatin calcium 10 MG Oral TabletPSN2c72feef-6742-4d8a-9515-89be4e430c4f1
859747rosuvastatin calcium 10 MG Oral TabletSCD2984f47e-9246-46d0-842e-43c540dd12a51
859747rosuvastatin calcium 10 MG Oral TabletSCD2c72feef-6742-4d8a-9515-89be4e430c4f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-365-017260303650190 TABLET in 1 BOTTLE (72603-365-01) 90 tablet2025-12-15NoNoCurrent
72603-365-02726030365021000 TABLET in 1 BOTTLE (72603-365-02) 1000 tablet2025-12-15NoNoCurrent