ROSUVASTATIN CALCIUM

Product NDC
61919-799
11-digit product format
619190799
Labeler code
61919
Product ID
61919-799_874bd64a-5af9-221e-e053-2995a90a6f79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROSUVASTATIN CALCIUN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA208898
Marketing category
ANDA
Marketing start
2019-02-12
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
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-799IInactivated by FDA2026-08-17
excluded packagepackage61919-79961919-799-30IInactivated by FDA2026-08-17

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-799-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-799-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-799-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-799-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-799-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-799-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-799-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-799-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-799-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-799-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-799-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-799-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-799-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-799-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-799-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61919-799-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61919-799-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61919-799-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61919-799-308dfbde2a14a4…c9ff85d89658…

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-799-302021-01-29C16284748780-1ba0f9c33-1c9d-a910-e053-dadaa90a0b85ROSUVASTATIN CALCIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-799-30ROSUVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-799-30EA - Each61919-79996b5193e-a929-42c9-a9b8-5457426a496612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-799ROSUVASTATIN CALCIUM TABLET, FILM COATED ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUN) TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 1 package rows20190425_7a8db339-b98c-6fab-e053-2a91aa0a1247.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSN7a8db339-b98c-6fab-e053-2a91aa0a12473
859419rosuvastatin calcium 40 MG Oral TabletPSN7a8db339-b98c-6fab-e053-2a91aa0a12473
859424rosuvastatin calcium 5 MG Oral TabletPSN7a8db339-b98c-6fab-e053-2a91aa0a12473
859751rosuvastatin calcium 20 MG Oral TabletSCD7a8db339-b98c-6fab-e053-2a91aa0a12473
859419rosuvastatin calcium 40 MG Oral TabletSCD7a8db339-b98c-6fab-e053-2a91aa0a12473
859424rosuvastatin calcium 5 MG Oral TabletSCD7a8db339-b98c-6fab-e053-2a91aa0a12473

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-799-306191907993030 in 1 BOTTLEHistorical