Rosuvastatin calcium

Product NDC
71335-1501
Requested package NDC
71335-1501-2
11-digit product format
713351501
Labeler code
71335
Product ID
71335-1501_a309752f-ed99-489e-b117-36adc6bfb224
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079172
Marketing category
ANDA
Marketing start
2016-07-19
Marketing end
0000-00-00
Substance
ROSUVASTATIN CALCIUM
Active strength
5 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage71335-150171335-1501-2DDiscontinued 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
A079172-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-07-19
A079172-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-07-19
A079172-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-07-19
A079172-004ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079172-001AB
A079172-002AB
A079172-003AB
A079172-004AB

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 06:07:402026-07A079172-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A079172-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A079172-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A079172-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079172-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079172-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079172-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079172-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079172-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079172-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079172-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079172-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A079172-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079172-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079172-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079172-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079172-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079172-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079172-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079172-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079172-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079172-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079172-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079172-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-07-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079172-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079172-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079172-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079172-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-07-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079172-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-07-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079172-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-07-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079172-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-07-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079172-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-07-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079172-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-07-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079172-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-07-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079172-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-07-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079172-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-07-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079172-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-07-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079172-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-07-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079172-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-07-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079172-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-07-19d8e5a09893c0…

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 06:07:402026-07A079172-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079172-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079172-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079172-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079172-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079172-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079172-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079172-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079172-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079172-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079172-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079172-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079172-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079172-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079172-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079172-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079172-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079172-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079172-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079172-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079172-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079172-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079172-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079172-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079172-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079172-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079172-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079172-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079172-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079172-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079172-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079172-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079172-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079172-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079172-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079172-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079172-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079172-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079172-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079172-004AB1d8e5a09893c0…

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rosuvastatin CalciumROSUVASTATIN CALCIUMRedpharm Drug57d1fb5b-1b85-7dd9-e063-6394a90a3fb12026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin CalciumROSUVASTATIN CALCIUMRedpharm Drug57d226e7-30f4-cecb-e063-6394a90a692f2026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin calciumROSUVASTATIN CALCIUMGlenmark Pharmaceutials Inc., USA392657a9-955c-42c2-814c-1890ece45afa2026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutions76568df9-1a56-4e23-ac84-28f3b72cc2422026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutions82308a25-97e8-44ba-a6c4-d6e03d08cd6a2026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin calciumROSUVASTATIN CALCIUMQPharma, Inc.4148e0b3-0340-9f3a-e063-6394a90afc962026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin calciumROSUVASTATIN CALCIUMProficient Rx LP8bd56c80-2f98-4b6e-809e-d0e981c3dcb32026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin calciumROSUVASTATIN CALCIUMREMEDYREPACK INC.94245f53-2892-4209-8c94-c32c87d5b1062026-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin calciumROSUVASTATIN CALCIUMNorthwind Health Company, LLCf80b8d59-2c22-8fff-e053-6294a90a2f9e2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin calciumROSUVASTATIN CALCIUMNorthwind Health Company, LLC1d86f10c-1e47-cefc-e063-6394a90a9f2e2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin calciumROSUVASTATIN CALCIUMNorthwind Health Company, LLCf80c5f1e-6a36-4b76-e053-6394a90a681d2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin CalciumROSUVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.3493b809-74b0-71b0-e063-6294a90a9a992025-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin calciumROSUVASTATIN CALCIUMREMEDYREPACK INC.f230f4fe-0dbd-4062-9e11-a3e74bcdcba82025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin calciumROSUVASTATIN CALCIUMREMEDYREPACK INC.c607da3c-47f5-4773-8391-2a7b0826d30e2025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin calciumROSUVASTATIN CALCIUMPreferred Pharmaceuticals Inc.,e432e043-c019-4d58-94ca-7c1d85f5cd402025-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin CalciumROSUVASTATIN CALCIUMNorthStar RxLLC17d71c80-fade-4735-acec-60738d26dd012025-08-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin calciumROSUVASTATIN CALCIUMProficient Rx LP45033c5f-4246-491a-8707-10f840ff2b6c2025-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutions3b556f65-fae9-436f-9cc5-3160d1c9b18a2024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutionse5decd64-cde1-4d8d-9853-7243fb0e17222024-06-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172
Rosuvastatin calciumROSUVASTATIN CALCIUMA-S Medication Solutionsf07922e5-a963-4ecf-86db-c1ae12f852242024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079172
application number: ANDA079172

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1501-27133515010290 TABLET, FILM COATED in 1 BOTTLE (71335-1501-2) 2020-08-070000-00-00NoNoCurrent