Rosuvastatin Calcium

Product NDC
50090-5188
11-digit product format
500905188
Labeler code
50090
Product ID
50090-5188_b2cd4d52-3c05-4110-bbf3-28a2d7495226
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206465
Marketing category
ANDA
Marketing start
2017-03-21
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 42.

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
A206465-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-03-21
A206465-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-21
A206465-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-21
A206465-004ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206465-001AB
A206465-002AB
A206465-003AB
A206465-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206465-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-03-21caaa826d4ba7…
2026-08-18 06:07:402026-07A206465-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-21caaa826d4ba7…
2026-08-18 06:07:402026-07A206465-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-21caaa826d4ba7…
2026-08-18 06:07:402026-07A206465-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206465-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206465-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206465-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206465-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206465-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206465-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206465-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206465-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206465-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206465-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206465-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206465-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206465-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206465-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206465-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206465-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206465-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206465-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206465-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206465-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206465-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206465-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206465-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206465-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206465-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-03-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206465-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206465-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206465-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206465-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-03-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206465-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206465-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206465-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206465-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-03-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206465-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-03-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206465-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-03-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206465-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-03-21d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206465-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206465-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206465-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206465-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206465-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206465-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206465-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206465-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206465-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206465-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206465-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206465-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206465-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206465-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206465-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206465-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206465-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206465-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206465-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206465-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206465-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206465-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206465-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206465-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206465-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206465-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206465-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206465-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206465-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206465-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206465-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206465-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206465-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206465-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206465-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206465-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206465-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206465-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206465-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206465-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Rosuvastatin Calcium
Listing expiration
2026-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac89adcd-3226-4a66-8902-0f0a33be159aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5188-0Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED3013
50090-5188-1Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED9013
50090-5188-2Rosuvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5188-0EA - Each50090-518883ea2567-8a64-4310-b745-67e176d3e2db12023-04-07
50090-5188-1EA - Each50090-5188d8c5e5d1-ffd7-4577-a41e-f4ba78870cda12023-02-06
50090-5188-2EA - Each50090-5188ef1dbb5c-e780-441b-8458-56c9bc307aa012023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5188ROSUVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 3 package rows20230317_ac89adcd-3226-4a66-8902-0f0a33be159a.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepack67da041b-7ad5-4309-86b3-8c30a5f9465e2026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206465
application number: ANDA206465
Rosuvastatin CalciumROSUVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.c2d9a04e-8c72-d487-e053-2a95a90a0fcd2026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206465
application number: ANDA206465
RosuvastatinROSUVASTATINQuallent Pharmaceuticals Health LLC0d12ae85-71bd-4818-a82d-fd068530bd872026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206465
application number: ANDA206465
Rosuvastatin CalciumROSUVASTATIN CALCIUMNorthwind Health Company, LLCe08b4f88-0713-1141-e053-2a95a90ae7b52026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206465
application number: ANDA206465
Rosuvastatin CalciumROSUVASTATIN CALCIUMAscend Laboratories, LLC4ccbaa83-d57a-421e-88a8-1cee42d4207b2025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206465
application number: ANDA206465
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutions7b2fc012-bf45-4a27-9e48-67926972918d2023-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206465
application number: ANDA206465
Rosuvastatin CalciumROSUVASTATIN CALCIUMProficient Rx LP76bbea68-52d8-4ba9-a772-0ba75a38f2eb2023-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206465
application number: ANDA206465
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutions0514e340-54a7-470c-8072-c8113fddf2d92023-04-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206465
application number: ANDA206465
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutionsac89adcd-3226-4a66-8902-0f0a33be159a2023-03-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206465
application number: ANDA206465
ndc (product): 50090-5188
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutions3aa55393-11c9-4c31-8697-ecaad8c788572023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206465
application number: ANDA206465

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSNac89adcd-3226-4a66-8902-0f0a33be159a13
859747rosuvastatin calcium 10 MG Oral TabletSCDac89adcd-3226-4a66-8902-0f0a33be159a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5188-05009051880030 TABLET, FILM COATED in 1 BOTTLE (50090-5188-0) 2020-09-290000-00-00NoNoCurrent
50090-5188-15009051880190 TABLET, FILM COATED in 1 BOTTLE (50090-5188-1) 2020-09-290000-00-00NoNoCurrent
50090-5188-250090518802100 TABLET, FILM COATED in 1 BOTTLE (50090-5188-2) 2023-03-13NoNoCurrent