Rosuvastatin calcium

Product NDC
68788-7086
11-digit product format
687887086
Labeler code
68788
Product ID
68788-7086_a24bcd70-cb0e-4ab5-b7df-a06e8d566878
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA206434
Marketing category
ANDA
Marketing start
2018-01-26
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
A206434-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31
A206434-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31
A206434-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31
A206434-004ROSUVASTATIN 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
A206434-001AB
A206434-002AB
A206434-003AB
A206434-004AB

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 06:07:402026-07A206434-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A206434-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A206434-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A206434-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206434-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206434-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206434-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206434-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206434-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206434-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206434-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206434-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206434-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206434-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206434-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206434-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206434-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206434-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206434-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206434-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206434-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206434-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206434-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206434-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206434-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206434-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206434-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206434-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206434-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206434-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206434-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206434-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206434-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206434-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206434-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206434-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206434-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206434-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206434-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206434-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…

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 06:07:402026-07A206434-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206434-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206434-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206434-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206434-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206434-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206434-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206434-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206434-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206434-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206434-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206434-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206434-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206434-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206434-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206434-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206434-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206434-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206434-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206434-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206434-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206434-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206434-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206434-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206434-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206434-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206434-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206434-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206434-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206434-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206434-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206434-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206434-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206434-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206434-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206434-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206434-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206434-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206434-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206434-004AB1d8e5a09893c0…

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
662c6f1a-ca1e-40ea-952d-122b680fdb89Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7086-2Rosuvastatin calcium20 in 1 BOTTLETABLET, FILM COATED206
68788-7086-3Rosuvastatin calcium30 in 1 BOTTLETABLET, FILM COATED306
68788-7086-6Rosuvastatin calcium60 in 1 BOTTLETABLET, FILM COATED606
68788-7086-9Rosuvastatin calcium90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7086ROSUVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 4 package rows20250112_662c6f1a-ca1e-40ea-952d-122b680fdb89.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMBryant Ranch Prepackbf40166a-4f73-47ff-938b-2bdbf7f000e42026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206434
application number: ANDA206434
RosuvastatinROSUVASTATINAccord Healthcare Inc.3ffe0294-3997-2755-e054-00144ff8d46c2025-11-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206434
application number: ANDA206434
Rosuvastatin calciumROSUVASTATIN CALCIUMPreferred Pharmaceuticals Inc.662c6f1a-ca1e-40ea-952d-122b680fdb892025-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206434
application number: ANDA206434
ndc (product): 68788-7086
RosuvastatinROSUVASTATINBryant Ranch Prepack0ad5b7de-e97d-4989-91e4-edae735438962024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206434
application number: ANDA206434
RosuvastatinROSUVASTATINBryant Ranch Prepackaa7443b0-9f75-47fc-a5ce-c7245444419c2024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206434
application number: ANDA206434
ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMProficient Rx LPeaf91ddd-0d4f-4c77-9dba-a2a3abb86ea42022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206434
application number: ANDA206434
Rosuvastatin calciumROSUVASTATIN CALCIUMProficient Rx LPaa64d28f-0926-4ff2-bb28-578e5ef233eb2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206434
application number: ANDA206434
Rosuvastatin calciumROSUVASTATIN CALCIUMProficient Rx LPa1b4d50b-eda3-437c-9c80-4d854361ddc22022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206434
application number: ANDA206434
Rosuvastatin calciumROSUVASTATIN CALCIUMProficient Rx LP5a874865-3cbe-4589-9787-046feb9a2c462022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206434
application number: ANDA206434
Rosuvastatin calciumROSUVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCa5ee9510-e691-49ec-a5cd-49e70371ee4d2019-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206434
application number: ANDA206434
Rosuvastatin calciumROSUVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLC410a0a03-6751-4c3d-82bf-c7c6a4081fdd2018-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206434
application number: ANDA206434
Rosuvastatin calciumROSUVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLC69dfa637-2a81-4c7e-8fef-d4b4ab4c3f252018-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206434
application number: ANDA206434

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN662c6f1a-ca1e-40ea-952d-122b680fdb896
859747rosuvastatin calcium 10 MG Oral TabletSCD662c6f1a-ca1e-40ea-952d-122b680fdb896

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7086-26878870860220 TABLET, FILM COATED in 1 BOTTLE (68788-7086-2) 2018-01-260000-00-00NoNoCurrent
68788-7086-36878870860330 TABLET, FILM COATED in 1 BOTTLE (68788-7086-3) 2018-01-260000-00-00NoNoCurrent
68788-7086-66878870860660 TABLET, FILM COATED in 1 BOTTLE (68788-7086-6) 2018-01-260000-00-00NoNoCurrent
68788-7086-96878870860990 TABLET, FILM COATED in 1 BOTTLE (68788-7086-9) 2018-01-260000-00-00NoNoCurrent