Rosuvastatin

Product NDC
70771-1482
Requested package NDC
70771-1482-5
11-digit product format
707711482
Labeler code
70771
Product ID
70771-1482_493a5304-a54c-41db-80b8-b2f25f09d829
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cadila Healthcare Limited
Application
ANDA206513
Marketing category
ANDA
Marketing start
2020-01-16
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70771-148270771-1482-5DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206513-001ROSUVASTATIN 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…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206513-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2019-03-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206513-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2019-03-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206513-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2019-03-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206513-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2019-03-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206513-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2019-03-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206513-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2019-03-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206513-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2019-03-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206513-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2019-03-01d8e5a09893c0…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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
RosuvastatinROSUVASTATINAiPing Pharmaceutical, Inc.913067e8-723b-4ce2-9ebc-3e10b0f0cf7a2026-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206513
application number: ANDA206513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1482-570771148205500 TABLET, FILM COATED in 1 BOTTLE (70771-1482-5) 2020-01-160000-00-00NoNoCurrent