Rosuvastatin Calcium

Product NDC
72205-005
11-digit product format
722050005
Labeler code
72205
Product ID
72205-005_62787a4a-6d53-43a3-a0b7-ed0b6037d18e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA208898
Marketing category
ANDA
Marketing start
2017-11-22
Substance
ROSUVASTATIN CALCIUM
Active strength
40 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 43.

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
A208898-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-22
A208898-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-22
A208898-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-22
A208898-004ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208898-001AB
A208898-002AB
A208898-003AB
A208898-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-2284e616aacf4f…
2026-09-14 22:38:342026-08A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-2284e616aacf4f…
2026-09-14 22:38:342026-08A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-2284e616aacf4f…
2026-09-14 22:38:342026-08A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-2284e616aacf4f…
2026-08-18 06:07:402026-07A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-22caaa826d4ba7…
2026-08-18 06:07:402026-07A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-22caaa826d4ba7…
2026-08-18 06:07:402026-07A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-22caaa826d4ba7…
2026-08-18 06:07:402026-07A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-225bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208898-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208898-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208898-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A208898-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A208898-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208898-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208898-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208898-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208898-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208898-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208898-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208898-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208898-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208898-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208898-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208898-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208898-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208898-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208898-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208898-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208898-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208898-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208898-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208898-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208898-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208898-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208898-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208898-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208898-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208898-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208898-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208898-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208898-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208898-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208898-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208898-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208898-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208898-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208898-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208898-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM40 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
d58f1f63-4bb6-413c-9730-ded3e8078618Available 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
72205-005-05Rosuvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED5009
72205-005-06Rosuvastatin Calcium100 in 1 CARTONTABLET, FILM COATED1009
72205-005-11Rosuvastatin Calcium10 in 1 BLISTER PACKTABLET, FILM COATED109
72205-005-30Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED309
72205-005-90Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED909
72205-005-99Rosuvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-005-30EA - Each72205-0051dd73169-0b52-4ed5-b73c-b63836f40c4212018-09-05
72205-005-90EA - Each72205-005536b11f0-33c6-4962-aaf3-6a5bd84c13f212018-10-11
72205-005-99EA - Each72205-0057290b378-f4de-417b-97db-0678fd20790a12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-005ROSUVASTATIN CALCIUM TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]9Current NDC, Legacy NDC, 6 package rows20250302_d58f1f63-4bb6-413c-9730-ded3e8078618.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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutions2e998dc7-e2a5-41e4-8758-aff545bb1f142023-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutions3a138e43-f123-47d1-b241-d3bcc7584e512023-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutions8046d4fa-bd89-49f7-8204-9eb49b6487482023-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutionsee4f7a00-b330-47ed-8440-7317b43753cf2023-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutionse24da1b9-e51d-489a-85f4-43227c2104772023-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859419rosuvastatin calcium 40 MG Oral TabletPSN8795a783-755d-426b-aa4f-1fc9965ba944101
859419rosuvastatin calcium 40 MG Oral TabletSCD8795a783-755d-426b-aa4f-1fc9965ba944101
859747rosuvastatin calcium 10 MG Oral TabletPSNd58f1f63-4bb6-413c-9730-ded3e80786189
859751rosuvastatin calcium 20 MG Oral TabletPSNd58f1f63-4bb6-413c-9730-ded3e80786189
859419rosuvastatin calcium 40 MG Oral TabletPSNd58f1f63-4bb6-413c-9730-ded3e80786189
859424rosuvastatin calcium 5 MG Oral TabletPSNd58f1f63-4bb6-413c-9730-ded3e80786189
859747rosuvastatin calcium 10 MG Oral TabletSCDd58f1f63-4bb6-413c-9730-ded3e80786189
859751rosuvastatin calcium 20 MG Oral TabletSCDd58f1f63-4bb6-413c-9730-ded3e80786189
859419rosuvastatin calcium 40 MG Oral TabletSCDd58f1f63-4bb6-413c-9730-ded3e80786189
859424rosuvastatin calcium 5 MG Oral TabletSCDd58f1f63-4bb6-413c-9730-ded3e80786189
859419rosuvastatin calcium 40 MG Oral TabletPSN99602058-4681-7cb5-e053-2995a90a099c7
859424rosuvastatin calcium 5 MG Oral TabletPSN99602058-4681-7cb5-e053-2995a90a099c7
859419rosuvastatin calcium 40 MG Oral TabletSCD99602058-4681-7cb5-e053-2995a90a099c7
859424rosuvastatin calcium 5 MG Oral TabletSCD99602058-4681-7cb5-e053-2995a90a099c7
859419rosuvastatin calcium 40 MG Oral TabletPSN8046d4fa-bd89-49f7-8204-9eb49b6487485
859419rosuvastatin calcium 40 MG Oral TabletSCD8046d4fa-bd89-49f7-8204-9eb49b6487485
859419rosuvastatin calcium 40 MG Oral TabletPSNee4f7a00-b330-47ed-8440-7317b43753cf4
859419rosuvastatin calcium 40 MG Oral TabletSCDee4f7a00-b330-47ed-8440-7317b43753cf4
859419rosuvastatin calcium 40 MG Oral TabletPSNdc7bfc79-9ee3-46e7-b55d-aba88648ad3b1
859419rosuvastatin calcium 40 MG Oral TabletSCDdc7bfc79-9ee3-46e7-b55d-aba88648ad3b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-005-0572205000505500 TABLET, FILM COATED in 1 BOTTLE (72205-005-05) 2019-02-250000-00-00NoNoCurrent
72205-005-0672205000506100 BLISTER PACK in 1 CARTON (72205-005-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-005-11) 100 blister pack2017-11-220000-00-00NoNoCurrent
72205-005-117220500051110 in 1 BLISTER PACKHistorical
72205-005-307220500053030 TABLET, FILM COATED in 1 BOTTLE (72205-005-30) 2017-11-220000-00-00NoNoCurrent
72205-005-907220500059090 TABLET, FILM COATED in 1 BOTTLE (72205-005-90) 2018-09-170000-00-00NoNoCurrent
72205-005-99722050005991000 TABLET, FILM COATED in 1 BOTTLE (72205-005-99) 2017-11-220000-00-00NoNoCurrent