Rosuvastatin Calcium

Product NDC
27808-156
Requested package NDC
27808-156-02
11-digit product format
278080156
Labeler code
27808
Product ID
27808-156_6c4547c4-9429-42e5-998f-e97f6a74f150
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cranbury Pharmaceuticals, LLC
Application
ANDA207408
Marketing category
ANDA
Marketing start
2018-01-08
Substance
ROSUVASTATIN CALCIUM
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A207408-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31
A207408-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31
A207408-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31
A207408-004ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207408-001AB
A207408-002AB
A207408-003AB
A207408-004AB

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 UTC2026-02A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207408-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A207408-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A207408-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A207408-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31d06236e962d9…

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 UTC2026-02A207408-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207408-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207408-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207408-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207408-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207408-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207408-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207408-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207408-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207408-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207408-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207408-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207408-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207408-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207408-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207408-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207408-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207408-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207408-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207408-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207408-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207408-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207408-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207408-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207408-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207408-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207408-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207408-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207408-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207408-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207408-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207408-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207408-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207408-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207408-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207408-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207408-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207408-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207408-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207408-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Rosuvastatin Calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM10 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
606d16fb-82e4-420d-9456-09997562b528Available 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
27808-156-01Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED9011
27808-156-02Rosuvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED100011
27808-156-03Rosuvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27808-156-01EA - Each27808-156d7ba2ac5-0ac1-4547-9e5e-4914863f763d12018-03-08
27808-156-03EA - Each27808-1562a19bb88-bb2e-4c11-bfa0-f7c2a915eb5f12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-156ROSUVASTATIN CALCIUM TABLET, FILM COATED [CRANBURY PHARMACEUTICALS, LLC]11Current NDC, Legacy NDC, 3 package rows20250330_606d16fb-82e4-420d-9456-09997562b528.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rosuvastatin CalciumROSUVASTATIN CALCIUMREMEDYREPACK INC.d9b83920-26ae-462a-ac10-33fd1ed7738f2026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207408
application number: ANDA207408
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepack4bd37cda-9928-456c-86be-aaccccf2e4502025-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207408
application number: ANDA207408
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepackebb0c5d6-d816-44fa-8422-82aa63076d552025-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207408
application number: ANDA207408
Rosuvastatin CalciumROSUVASTATIN CALCIUMGolden State Medical Supply, Inc.7c3af5aa-2223-463a-e053-2a91aa0a16f92025-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207408
application number: ANDA207408
Rosuvastatin CalciumROSUVASTATIN CALCIUMCranbury Pharmaceuticals, LLC606d16fb-82e4-420d-9456-09997562b5282025-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207408
application number: ANDA207408
ndc (package): 27808-156-02
ndc (product): 27808-156
ndc11 (package): 27808015602
Rosuvastatin CalciumROSUVASTATIN CALCIUMBryant Ranch Prepackc277c6fd-f8dd-41d8-8686-38c25d05d1922024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207408
application number: ANDA207408
Rosuvastatin CalciumROSUVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCab6c1601-5152-443c-98a0-876660d533e82023-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207408
application number: ANDA207408
Rosuvastatin CalciumROSUVASTATIN CALCIUMProficient Rx LPdcc22d05-cff6-42f9-b9fa-930f2084753f2022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207408
application number: ANDA207408

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN4bd37cda-9928-456c-86be-aaccccf2e450102
859747rosuvastatin calcium 10 MG Oral TabletSCD4bd37cda-9928-456c-86be-aaccccf2e450102
859747rosuvastatin calcium 10 MG Oral TabletPSN606d16fb-82e4-420d-9456-09997562b52811
859751rosuvastatin calcium 20 MG Oral TabletPSN606d16fb-82e4-420d-9456-09997562b52811
859419rosuvastatin calcium 40 MG Oral TabletPSN606d16fb-82e4-420d-9456-09997562b52811
859424rosuvastatin calcium 5 MG Oral TabletPSN606d16fb-82e4-420d-9456-09997562b52811
859747rosuvastatin calcium 10 MG Oral TabletSCD606d16fb-82e4-420d-9456-09997562b52811
859751rosuvastatin calcium 20 MG Oral TabletSCD606d16fb-82e4-420d-9456-09997562b52811
859419rosuvastatin calcium 40 MG Oral TabletSCD606d16fb-82e4-420d-9456-09997562b52811
859424rosuvastatin calcium 5 MG Oral TabletSCD606d16fb-82e4-420d-9456-09997562b52811
859747rosuvastatin calcium 10 MG Oral TabletPSN7c3af5aa-2223-463a-e053-2a91aa0a16f910
859751rosuvastatin calcium 20 MG Oral TabletPSN7c3af5aa-2223-463a-e053-2a91aa0a16f910
859419rosuvastatin calcium 40 MG Oral TabletPSN7c3af5aa-2223-463a-e053-2a91aa0a16f910
859424rosuvastatin calcium 5 MG Oral TabletPSN7c3af5aa-2223-463a-e053-2a91aa0a16f910
859747rosuvastatin calcium 10 MG Oral TabletSCD7c3af5aa-2223-463a-e053-2a91aa0a16f910
859751rosuvastatin calcium 20 MG Oral TabletSCD7c3af5aa-2223-463a-e053-2a91aa0a16f910
859419rosuvastatin calcium 40 MG Oral TabletSCD7c3af5aa-2223-463a-e053-2a91aa0a16f910
859424rosuvastatin calcium 5 MG Oral TabletSCD7c3af5aa-2223-463a-e053-2a91aa0a16f910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
27808-156-02278080156021000 TABLET, FILM COATED in 1 BOTTLE (27808-156-02) 2025-05-01NoNoCurrent