Rosuvastatin calcium

Product NDC
71205-077
11-digit product format
712050077
Labeler code
71205
Product ID
71205-077_646857c5-dccd-4437-93f0-6b3c7529718f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA079171
Marketing category
ANDA
Marketing start
2016-07-19
Marketing end
0000-00-00
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
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71205-077DDiscontinued by firm2026-10-15
excluded packagepackage71205-07771205-077-30DDiscontinued by firm2026-10-15
excluded packagepackage71205-07771205-077-60DDiscontinued by firm2026-10-15
excluded packagepackage71205-07771205-077-90DDiscontinued by firm2026-10-15

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 · 8 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 packagepackage71205-077-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-077-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-077-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-077-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-077-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-077-60f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A079171-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19
A079171-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19
A079171-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19
A079171-004ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-19

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19c2088c7a36db…
2026-10-15 13:18:302026-09A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19c2088c7a36db…
2026-10-15 13:18:302026-09A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19c2088c7a36db…
2026-10-15 13:18:302026-09A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-19c2088c7a36db…
2026-09-14 22:38:342026-08A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-1984e616aacf4f…
2026-08-18 06:07:402026-07A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-192680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079171-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079171-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079171-003AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079171-004AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079171-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A079171-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A079171-003AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A079171-004AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079171-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A079171-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A079171-003AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A079171-004AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079171-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079171-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079171-003AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079171-004AB1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-077-30EA - Each71205-0779871c501-86a7-42bd-8ae0-1263b7208c4512018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-077ROSUVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]3Legacy NDC20191030_32747a7a-450d-4161-87b0-0ca4bdc73ef7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-077-307120500773030 TABLET, FILM COATED in 1 BOTTLE (71205-077-30) 2018-08-010000-00-00NoNoCurrent
71205-077-607120500776060 TABLET, FILM COATED in 1 BOTTLE (71205-077-60) 2018-08-010000-00-00NoNoCurrent
71205-077-907120500779090 TABLET, FILM COATED in 1 BOTTLE (71205-077-90) 2018-08-010000-00-00NoNoCurrent