Rosuvastatin

Product NDC
31722-885
Requested package NDC
31722-885-30
11-digit product format
317220885
Labeler code
31722
Product ID
31722-885_49d450b0-95af-a362-e063-6294a90a3e99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA207616
Marketing category
ANDA
Marketing start
2016-10-29
Substance
ROSUVASTATIN CALCIUM
Active strength
40 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 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
A207616-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31
A207616-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31
A207616-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31
A207616-004ROSUVASTATIN 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
A207616-001AB
A207616-002AB
A207616-003AB
A207616-004AB

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 UTC2026-02A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207616-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207616-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALAB2016-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A207616-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A207616-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A207616-004ROSUVASTATIN 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 UTC2026-02A207616-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207616-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207616-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207616-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207616-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207616-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207616-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207616-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207616-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207616-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207616-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207616-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207616-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207616-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207616-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207616-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207616-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207616-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207616-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207616-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207616-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207616-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207616-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207616-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207616-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207616-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207616-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207616-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207616-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207616-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207616-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207616-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207616-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207616-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207616-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207616-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207616-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207616-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207616-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207616-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM40 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
7778df5a-82c1-4a86-8867-a3325da025ecAvailable on FDA.report

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
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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-885-05Rosuvastatin500 in 1 BOTTLETABLET, FILM COATED5006
31722-885-10Rosuvastatin1000 in 1 BOTTLETABLET, FILM COATED10006
31722-885-30Rosuvastatin30 in 1 BOTTLETABLET, FILM COATED306
31722-885-31Rosuvastatin100 in 1 CARTONTABLET, FILM COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-885-30EA - Each31722-885ddc5e1e3-9ceb-4fef-9e8e-dd0df249de8b12016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-885ROSUVASTATIN (ROSUVASTATIN) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 4 package rows20250213_7778df5a-82c1-4a86-8867-a3325da025ec.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RosuvastatinROSUVASTATINCamber Pharmaceuticals, Inc.7778df5a-82c1-4a86-8867-a3325da025ec2026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207616
application number: ANDA207616
ndc (package): 31722-885-30
ndc (product): 31722-885
ndc11 (package): 31722088530
RosuvastatinROSUVASTATINCardinal Health 107, LLC0f7fad2c-fc46-4ebc-b55b-6534da99e0532026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207616
application number: ANDA207616
RosuvastatinROSUVASTATINBryant Ranch Prepacke6b86b67-62c7-43cc-8174-b2b8e0a607112026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207616
application number: ANDA207616
RosuvastatinROSUVASTATINPreferred Pharmaceuticals Inc.979588e5-d266-4728-aa58-36cd6a2175842025-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207616
application number: ANDA207616
RosuvastatinROSUVASTATINPreferred Pharmaceuticals Inc.92a58577-b549-4143-abd0-391a07ed714d2025-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207616
application number: ANDA207616
RosuvastatinROSUVASTATINAvPAK7cd6ae8d-aa67-60db-e053-2991aa0a0ede2025-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207616
application number: ANDA207616
RosuvastatinROSUVASTATINProficient Rx LPf42139aa-bb38-4791-b41e-cd8f2c9225292025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207616
application number: ANDA207616

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN7778df5a-82c1-4a86-8867-a3325da025ec6
859751rosuvastatin calcium 20 MG Oral TabletPSN7778df5a-82c1-4a86-8867-a3325da025ec6
859419rosuvastatin calcium 40 MG Oral TabletPSN7778df5a-82c1-4a86-8867-a3325da025ec6
859424rosuvastatin calcium 5 MG Oral TabletPSN7778df5a-82c1-4a86-8867-a3325da025ec6
859747rosuvastatin calcium 10 MG Oral TabletSCD7778df5a-82c1-4a86-8867-a3325da025ec6
859751rosuvastatin calcium 20 MG Oral TabletSCD7778df5a-82c1-4a86-8867-a3325da025ec6
859419rosuvastatin calcium 40 MG Oral TabletSCD7778df5a-82c1-4a86-8867-a3325da025ec6
859424rosuvastatin calcium 5 MG Oral TabletSCD7778df5a-82c1-4a86-8867-a3325da025ec6
859747rosuvastatin calcium 10 MG Oral TabletPSN7cd6ae8d-aa67-60db-e053-2991aa0a0ede4
859751rosuvastatin calcium 20 MG Oral TabletPSN7cd6ae8d-aa67-60db-e053-2991aa0a0ede4
859419rosuvastatin calcium 40 MG Oral TabletPSN7cd6ae8d-aa67-60db-e053-2991aa0a0ede4
859747rosuvastatin calcium 10 MG Oral TabletSCD7cd6ae8d-aa67-60db-e053-2991aa0a0ede4
859751rosuvastatin calcium 20 MG Oral TabletSCD7cd6ae8d-aa67-60db-e053-2991aa0a0ede4
859419rosuvastatin calcium 40 MG Oral TabletSCD7cd6ae8d-aa67-60db-e053-2991aa0a0ede4
859419rosuvastatin calcium 40 MG Oral TabletPSN92a58577-b549-4143-abd0-391a07ed714d2
859419rosuvastatin calcium 40 MG Oral TabletSCD92a58577-b549-4143-abd0-391a07ed714d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-885-303172208853030 TABLET, FILM COATED in 1 BOTTLE (31722-885-30) 2016-10-290000-00-00NoNoCurrent