ROSUVASTATIN TABLETS

Manufacturer
Zydus Lifesciences Limited
Effective date
2022-07-09
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:57:18

Label at a glance#

ProductRosuvastatin
Active ingredientROSUVASTATIN CALCIUM
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1481-3

Rosuvastatin Calcium Tablets, 5 mg

30 Tablets

Rx only

Rosuvastatin Ca Tablets
Rosuvastatin Ca Tablets

NDC 70771-1482-3

Rosuvastatin Calcium Tablets, 10 mg

30 Tablets

Rx only

Rosuvastatin Ca Tablets
Rosuvastatin Ca Tablets

NDC 70771-1483-3

Rosuvastatin Calcium Tablets, 20 mg

30 Tablets

Rx only

Rosuvastatin Ca Tablets
Rosuvastatin Ca Tablets

NDC 70771-1484-3

Rosuvastatin Calcium Tablets, 40 mg

30 Tablets

Rx only

Rosuvastatin Ca Tablets
Rosuvastatin Ca Tablets

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A206513-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-03-01
A206513-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-03-01
A206513-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-03-01
A206513-004ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-03-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206513-001AB
A206513-002AB
A206513-003AB
A206513-004AB

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A206513-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-03-01c2088c7a36db…
2026-10-15 13:18:302026-09A206513-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-03-01c2088c7a36db…
2026-10-15 13:18:302026-09A206513-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-03-01c2088c7a36db…
2026-10-15 13:18:302026-09A206513-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-03-01c2088c7a36db…
2026-09-14 22:38:342026-08A206513-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-03-0184e616aacf4f…
2026-09-14 22:38:342026-08A206513-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-03-0184e616aacf4f…
2026-09-14 22:38:342026-08A206513-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-03-0184e616aacf4f…
2026-09-14 22:38:342026-08A206513-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-03-0184e616aacf4f…
2026-08-18 06:07:402026-07A206513-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07A206513-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07A206513-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-03-01caaa826d4ba7…
2026-08-18 06:07:402026-07A206513-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-03-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206513-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206513-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206513-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206513-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-03-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206513-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206513-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206513-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206513-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206513-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206513-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206513-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206513-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206513-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2019-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206513-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2019-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206513-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2019-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206513-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2019-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206513-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2019-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206513-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2019-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206513-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2019-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206513-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2019-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206513-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2019-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206513-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2019-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206513-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2019-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206513-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2019-03-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206513-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2019-03-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206513-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2019-03-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206513-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2019-03-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206513-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2019-03-012680178bc6a6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A206513-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A206513-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A206513-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A206513-004AB1c2088c7a36db…
2026-09-14 22:38:342026-08A206513-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A206513-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A206513-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A206513-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A206513-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206513-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206513-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206513-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206513-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206513-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206513-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206513-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206513-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206513-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206513-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206513-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206513-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206513-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206513-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206513-004AB16a471c1ec25d…
2019-07-19 19:46 UTC2019-07A206513-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A206513-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A206513-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A206513-004AB1ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206513-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206513-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206513-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206513-004AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5a150385-534d-4d1d-96e8-cac9bea0d172460f9985-cfe3-43ca-a023-6ebf98b878802024-08-20Exact identifier
spl set id: 460f9985-cfe3-43ca-a023-6ebf98b87880

Reported adverse events (FAERS/openFDA)#

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