Rosuvastatin Calcium

Product NDC
70518-1819
Requested package NDC
70518-1819-1
11-digit product format
705181819
Labeler code
70518
Product ID
70518-1819_4db2337c-a326-0d13-e063-6394a90a9aeb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208898
Marketing category
ANDA
Marketing start
2019-01-24
Substance
ROSUVASTATIN CALCIUM
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-181970518-1819-1DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-10-29 15:01 UTC2024-10A208898-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2017-11-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A208898-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2017-11-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A208898-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2017-11-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A208898-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2017-11-22d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-10-29 15:01 UTC2024-10A208898-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208898-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208898-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208898-004AB1d06236e962d9…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (package): 70518-1819-1
ndc (product): 70518-1819
ndc11 (package): 70518181901
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

Additional Listing Data#

Finished product
Yes
Brand name base
Rosuvastatin Calcium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
83MVU38M7QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
859751Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
11fad602-16c2-4c1f-bdf1-867d95f063caAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1819-0Rosuvastatin Calcium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9014
70518-1819-1Rosuvastatin Calcium45 in 1 BOTTLE, PLASTICTABLET, FILM COATED4514
70518-1819-2Rosuvastatin Calcium30 in 1 BLISTER PACKTABLET, FILM COATED3014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1819ROSUVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 3 package rows20250228_11fad602-16c2-4c1f-bdf1-867d95f063ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSN11fad602-16c2-4c1f-bdf1-867d95f063ca14
859751rosuvastatin calcium 20 MG Oral TabletSCD11fad602-16c2-4c1f-bdf1-867d95f063ca14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1819-17051818190145 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1819-1) 2020-10-080000-00-00NoNoCurrent