Rosuvastatin Calcium

Product NDC
69367-359
Requested package NDC
69367-359-01
11-digit product format
693670359
Labeler code
69367
Product ID
69367-359_447c034b-bd46-2a37-e063-6394a90a4feb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA207062
Marketing category
ANDA
Marketing start
2024-12-01
Substance
ROSUVASTATIN CALCIUM
Active strength
5 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
A207062-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31
A207062-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31
A207062-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31
A207062-004ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207062-001AB
A207062-002AB
A207062-003AB
A207062-004AB

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 UTC2026-02A207062-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207062-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207062-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207062-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207062-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207062-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207062-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207062-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207062-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207062-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207062-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207062-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207062-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207062-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207062-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207062-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207062-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207062-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207062-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207062-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207062-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207062-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207062-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207062-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207062-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207062-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207062-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207062-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207062-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207062-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207062-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207062-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207062-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207062-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207062-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207062-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207062-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A207062-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A207062-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A207062-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207062-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207062-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207062-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207062-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207062-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207062-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207062-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207062-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207062-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207062-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207062-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207062-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207062-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207062-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207062-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207062-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207062-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207062-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207062-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207062-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207062-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207062-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207062-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207062-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207062-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207062-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207062-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207062-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207062-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207062-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207062-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207062-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207062-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207062-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207062-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207062-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207062-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207062-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207062-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207062-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM5 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
02797697-300a-43db-92cf-9b78f08626beAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-359-01Rosuvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1006
69367-359-05Rosuvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED5006
69367-359-09Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED906
69367-359-10Rosuvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED10006
69367-359-30Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-359-05EA - Each69367-3599dc923ee-df66-4c3e-acec-790b4c5c072112024-11-05
69367-359-09EA - Each69367-35925073205-0a7d-450a-8de1-08a5335de58a12024-11-05
69367-359-10EA - Each69367-359b45d8c29-2056-48bb-827e-5f7de518408512024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-359ROSUVASTATIN CALCIUM TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC]3Current NDC, 5 package rows20241202_02797697-300a-43db-92cf-9b78f08626be.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rosuvastatin CalciumROSUVASTATIN CALCIUMWestminster Pharmaceuticals, LLC02797697-300a-43db-92cf-9b78f08626be2025-11-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207062
application number: ANDA207062
ndc (package): 69367-359-01
ndc (product): 69367-359
ndc11 (package): 69367035901
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutions9ac62b17-38d3-4299-b36a-55db1dd9a8ec2025-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207062
application number: ANDA207062
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutionsde59ab29-4266-4d8d-934c-8d6cf502a8a32025-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207062
application number: ANDA207062
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutionsdc412660-67d4-4371-a6f0-bdd1b5f28bbd2025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207062
application number: ANDA207062
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutionsa1021325-c108-41b9-91dc-f1202730bfd12025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207062
application number: ANDA207062

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN02797697-300a-43db-92cf-9b78f08626be6
859751rosuvastatin calcium 20 MG Oral TabletPSN02797697-300a-43db-92cf-9b78f08626be6
859419rosuvastatin calcium 40 MG Oral TabletPSN02797697-300a-43db-92cf-9b78f08626be6
859424rosuvastatin calcium 5 MG Oral TabletPSN02797697-300a-43db-92cf-9b78f08626be6
859747rosuvastatin calcium 10 MG Oral TabletSCD02797697-300a-43db-92cf-9b78f08626be6
859751rosuvastatin calcium 20 MG Oral TabletSCD02797697-300a-43db-92cf-9b78f08626be6
859419rosuvastatin calcium 40 MG Oral TabletSCD02797697-300a-43db-92cf-9b78f08626be6
859424rosuvastatin calcium 5 MG Oral TabletSCD02797697-300a-43db-92cf-9b78f08626be6
859424rosuvastatin calcium 5 MG Oral TabletPSNa1021325-c108-41b9-91dc-f1202730bfd11
859424rosuvastatin calcium 5 MG Oral TabletPSNdc412660-67d4-4371-a6f0-bdd1b5f28bbd1
859424rosuvastatin calcium 5 MG Oral TabletSCDa1021325-c108-41b9-91dc-f1202730bfd11
859424rosuvastatin calcium 5 MG Oral TabletSCDdc412660-67d4-4371-a6f0-bdd1b5f28bbd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69367-359-0169367035901100 TABLET, FILM COATED in 1 BOTTLE (69367-359-01) 2024-12-01NoNoCurrent