Rosuvastatin Calcium

Product NDC
42677-301
11-digit product format
426770301
Labeler code
42677
Product ID
42677-301_47b31d1c-f321-11d2-e063-6294a90af883
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Shandong New Time Pharmaceutical Co., Ltd.
Application
ANDA207375
Marketing category
ANDA
Marketing start
2022-01-22
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
2027-12-31
Current FDA listing
Yes

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
A207375-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-05-07
A207375-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-05-07
A207375-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-05-07
A207375-004ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207375-001AB
A207375-002AB
A207375-003AB
A207375-004AB

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 06:07:402026-07A207375-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07A207375-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07A207375-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07A207375-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-05-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207375-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207375-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207375-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207375-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-05-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207375-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207375-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207375-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207375-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-05-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A207375-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207375-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207375-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207375-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-05-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207375-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207375-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207375-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207375-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-05-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207375-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-05-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207375-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-05-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207375-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-05-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207375-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-05-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207375-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-05-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207375-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-05-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207375-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-05-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207375-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-05-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207375-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-05-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207375-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-05-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207375-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-05-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207375-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-05-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207375-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-05-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207375-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-05-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207375-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-05-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207375-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-05-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207375-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2019-05-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207375-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-05-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207375-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-05-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207375-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-05-07d8e5a09893c0…

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 06:07:402026-07A207375-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207375-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207375-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207375-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207375-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207375-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207375-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207375-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207375-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207375-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207375-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207375-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207375-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207375-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207375-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207375-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207375-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207375-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207375-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207375-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207375-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207375-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207375-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207375-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207375-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207375-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207375-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207375-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207375-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207375-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207375-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207375-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207375-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207375-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207375-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207375-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207375-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207375-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207375-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207375-004AB1d8e5a09893c0…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM5 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
859419Internal RxNorm lookup
859424Internal RxNorm lookup
859747Internal RxNorm lookup
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
ae865404-ecf4-41a8-b40b-62f887c220f2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42677-301-01Rosuvastatin Calcium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9011
42677-301-02Rosuvastatin Calcium500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50011
42677-301-01Rosuvastatin Calcium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902
42677-301-02Rosuvastatin Calcium500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42677-301ROSUVASTATIN CALCIUM TABLET, FILM COATED [SHANDONG NEW TIME PHARMACEUTICAL CO., LTD.]10Current NDC, Legacy NDC, 2 package rows20241127_ce767751-696f-4750-8438-a276ae999137.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rosuvastatin CalciumROSUVASTATIN CALCIUMShandong New Time Pharmaceutical Co., Ltd.ae865404-ecf4-41a8-b40b-62f887c220f22026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207375
application number: ANDA207375
ndc (product): 42677-301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSNce767751-696f-4750-8438-a276ae99913711
859424rosuvastatin calcium 5 MG Oral TabletPSNce767751-696f-4750-8438-a276ae99913711
859747rosuvastatin calcium 10 MG Oral TabletSCDce767751-696f-4750-8438-a276ae99913711
859424rosuvastatin calcium 5 MG Oral TabletSCDce767751-696f-4750-8438-a276ae99913711
859747rosuvastatin calcium 10 MG Oral TabletPSNae865404-ecf4-41a8-b40b-62f887c220f22
859751rosuvastatin calcium 20 MG Oral TabletPSNae865404-ecf4-41a8-b40b-62f887c220f22
859419rosuvastatin calcium 40 MG Oral TabletPSNae865404-ecf4-41a8-b40b-62f887c220f22
859424rosuvastatin calcium 5 MG Oral TabletPSNae865404-ecf4-41a8-b40b-62f887c220f22
859747rosuvastatin calcium 10 MG Oral TabletSCDae865404-ecf4-41a8-b40b-62f887c220f22
859751rosuvastatin calcium 20 MG Oral TabletSCDae865404-ecf4-41a8-b40b-62f887c220f22
859419rosuvastatin calcium 40 MG Oral TabletSCDae865404-ecf4-41a8-b40b-62f887c220f22
859424rosuvastatin calcium 5 MG Oral TabletSCDae865404-ecf4-41a8-b40b-62f887c220f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42677-301-014267703010190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-301-01) 2022-01-220000-00-00NoNoCurrent
42677-301-0242677030102500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-301-02) 2022-01-220000-00-00NoNoCurrent