Rosuvastatin Calcium

Product NDC
68788-4047
11-digit product format
687884047
Labeler code
68788
Product ID
68788-4047_1eb971e3-de67-46ae-a8ef-8a7d2805cfdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA207626
Marketing category
ANDA
Marketing start
2025-10-28
Substance
ROSUVASTATIN CALCIUM
Active strength
20 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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM20 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
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
1eb971e3-de67-46ae-a8ef-8a7d2805cfddAvailable 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
68788-4047-2Rosuvastatin Calcium20 in 1 BOTTLETABLET201
68788-4047-3Rosuvastatin Calcium30 in 1 BOTTLETABLET301
68788-4047-6Rosuvastatin Calcium60 in 1 BOTTLETABLET601
68788-4047-9Rosuvastatin Calcium90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4047-2EA - Each68788-40472ae4e3e8-4348-4c93-9f05-2814bd815e0812026-03-17
68788-4047-3EA - Each68788-40470950cf3b-8b95-49aa-9afe-8bdee4006c5912026-03-17
68788-4047-6EA - Each68788-4047824a74b0-9cc2-4e0a-8a54-1a98c989a2bf12026-03-17
68788-4047-9EA - Each68788-4047796db6f6-539c-462e-956c-21696021924512026-03-17

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 · 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
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
ndc (product): 68788-4047
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSN1eb971e3-de67-46ae-a8ef-8a7d2805cfdd1
859751rosuvastatin calcium 20 MG Oral TabletSCD1eb971e3-de67-46ae-a8ef-8a7d2805cfdd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4047-26878840470220 TABLET in 1 BOTTLE (68788-4047-2) 20 tablet2025-10-28NoNoCurrent
68788-4047-36878840470330 TABLET in 1 BOTTLE (68788-4047-3) 30 tablet2025-10-28NoNoCurrent
68788-4047-66878840470660 TABLET in 1 BOTTLE (68788-4047-6) 60 tablet2025-10-28NoNoCurrent
68788-4047-96878840470990 TABLET in 1 BOTTLE (68788-4047-9) 90 tablet2025-10-28NoNoCurrent