Rosuvastatin Calcium

Product NDC
69539-160
11-digit product format
695390160
Labeler code
69539
Product ID
69539-160_d60d5829-60cf-407c-8b23-45f010949311
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
MSN LABORATORIES PRIVATE LIMITED
Application
ANDA208898
Marketing category
ANDA
Marketing start
2019-05-07
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
2022-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69539-160DDiscontinued by firm2026-08-17
excluded packagepackage69539-16069539-160-05DDiscontinued by firm2026-08-17
excluded packagepackage69539-16069539-160-06DDiscontinued by firm2026-08-17
excluded packagepackage69539-16069539-160-90DDiscontinued by firm2026-08-17
excluded packagepackage69539-16069539-160-99DDiscontinued 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 · 5 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage69539-160-05
excluded packagepackage69539-160-90
excluded packagepackage69539-160-06
excluded packagepackage69539-160-99

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
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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A208898-001ROSUVASTATIN 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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-22d8e5a09893c0…

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 06:07:402026-07A208898-001AB1caaa826d4ba7…
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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208898-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208898-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208898-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208898-004AB1d8e5a09893c0…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69539-160ROSUVASTATIN CALCIUM TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED]16Legacy NDC20250201_ec43549b-a0c6-4350-9568-8ebf1766303b.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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rosuvastatin CalciumROSUVASTATIN CALCIUMREMEDYREPACK INC.11fad602-16c2-4c1f-bdf1-867d95f063ca2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
ROSUVASTATINROSUVASTATINDIRECT RX99602058-4681-7cb5-e053-2995a90a099c2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.be73cea2-f89a-e4c5-e053-2a95a90a9cce2026-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMNorthwind Health Company, LLCf2a1008e-963c-9999-e053-2a95a90ae7262026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMNorthwind Health Company, LLCe3d92523-2dbe-930b-e053-2a95a90ac3f22026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMPreferred Pharmaceuticals Inc.b94b5b36-c04e-45ee-b933-59c4302f26612025-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMPreferred Pharmaceuticals, Inc.6ef51f7c-2899-4b09-bf8b-09e5b4ac34242025-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMPreferred Pharmaceuticals Inc.31b3894a-1139-4f07-ac29-dda53844dc4b2025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMQuallent Pharmaceuticals Health LLC6f978191-775e-4745-9c07-99e5be888afe2025-02-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMProficient Rx LPdc7bfc79-9ee3-46e7-b55d-aba88648ad3b2024-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMNovadoz Pharmaceuticals LLCd58f1f63-4bb6-413c-9730-ded3e80786182024-11-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepacka9a5641f-9b7d-4a98-8dac-a3c53dde861f2024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepack199df185-dab0-4de1-95f7-a70e57b9c2b12024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutionsaaadbf01-9cf4-4898-9a96-f0a20d55702b2024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.9e694f6a-63a0-55e9-e053-2995a90a10fe2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.a2155aff-bf13-3f00-e053-2995a90a4d1d2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepackd6645266-9626-430e-bf04-b6426525ae0a2024-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMProficient Rx LP3a03022c-ef11-4a68-829f-fae2d31969df2024-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMA-S Medication Solutions7ec15f53-a7ec-4be5-9f26-d1078117b18b2023-12-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepack8795a783-755d-426b-aa4f-1fc9965ba9442023-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208898
application number: ANDA208898

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69539-160-0569539016005500 TABLET, FILM COATED in 1 BOTTLE (69539-160-05) 2019-05-070000-00-00NoNoCurrent
69539-160-0669539016006100 BLISTER PACK in 1 CARTON (69539-160-06) > 10 TABLET, FILM COATED in 1 BLISTER PACK (69539-160-11) 100 blister pack2019-05-070000-00-00NoNoCurrent
69539-160-906953901609090 TABLET, FILM COATED in 1 BOTTLE (69539-160-90) 2019-05-070000-00-00NoNoCurrent
69539-160-99695390160991000 TABLET, FILM COATED in 1 BOTTLE (69539-160-99) 2019-05-070000-00-00NoNoCurrent