Simvastatin

Product NDC
71205-070
11-digit product format
712050070
Labeler code
71205
Product ID
71205-070_1bfa53ed-bcef-4864-81b9-e36a2016a7d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076052
Marketing category
ANDA
Marketing start
2006-06-27
Marketing end
0000-00-00
Substance
SIMVASTATIN
Active strength
5 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 productproduct71205-070DDiscontinued by firm2026-08-17
excluded packagepackage71205-07071205-070-30DDiscontinued by firm2026-08-17
excluded packagepackage71205-07071205-070-60DDiscontinued by firm2026-08-17
excluded packagepackage71205-07071205-070-90DDiscontinued by firm2026-08-17

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 packagepackage71205-070-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-070-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-070-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-070-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-070-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-070-60f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076052-001SIMVASTATINSIMVASTATIN5MGTABLET / ORAL2006-06-23
A076052-002SIMVASTATINSIMVASTATIN10MGTABLET / ORAL2006-06-23
A076052-003SIMVASTATINSIMVASTATIN20MGTABLET / ORAL2006-06-23
A076052-004SIMVASTATINSIMVASTATIN40MGTABLET / ORAL2006-06-23
A076052-005SIMVASTATINSIMVASTATIN80MGTABLET / ORAL2006-12-20

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 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076052-001SIMVASTATIN5MGTABLET / ORAL2006-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076052-002SIMVASTATIN10MGTABLET / ORAL2006-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076052-003SIMVASTATIN20MGTABLET / ORAL2006-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076052-004SIMVASTATIN40MGTABLET / ORAL2006-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076052-005SIMVASTATIN80MGTABLET / ORAL2006-12-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076052-001SIMVASTATIN5MGTABLET / ORAL2006-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076052-002SIMVASTATIN10MGTABLET / ORAL2006-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076052-003SIMVASTATIN20MGTABLET / ORAL2006-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076052-004SIMVASTATIN40MGTABLET / ORAL2006-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076052-005SIMVASTATIN80MGTABLET / ORAL2006-12-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076052-001SIMVASTATIN5MGTABLET / ORAL2006-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076052-002SIMVASTATIN10MGTABLET / ORAL2006-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076052-003SIMVASTATIN20MGTABLET / ORAL2006-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076052-004SIMVASTATIN40MGTABLET / ORAL2006-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076052-005SIMVASTATIN80MGTABLET / ORAL2006-12-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076052-001SIMVASTATIN5MGTABLET / ORAL2006-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076052-002SIMVASTATIN10MGTABLET / ORAL2006-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076052-003SIMVASTATIN20MGTABLET / ORAL2006-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076052-004SIMVASTATIN40MGTABLET / ORAL2006-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076052-005SIMVASTATIN80MGTABLET / ORAL2006-12-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076052-001SIMVASTATIN5MGTABLET / ORAL2006-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076052-002SIMVASTATIN10MGTABLET / ORAL2006-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076052-003SIMVASTATIN20MGTABLET / ORAL2006-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076052-004SIMVASTATIN40MGTABLET / ORAL2006-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076052-005SIMVASTATIN80MGTABLET / ORAL2006-12-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076052-001SIMVASTATIN5MGTABLET / ORAL2006-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076052-002SIMVASTATIN10MGTABLET / ORAL2006-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076052-003SIMVASTATIN20MGTABLET / ORAL2006-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076052-004SIMVASTATIN40MGTABLET / ORAL2006-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076052-005SIMVASTATIN80MGTABLET / ORAL2006-12-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076052-001SIMVASTATIN5MGTABLET / ORAL2006-06-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076052-002SIMVASTATIN10MGTABLET / ORAL2006-06-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076052-003SIMVASTATIN20MGTABLET / ORAL2006-06-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076052-004SIMVASTATIN40MGTABLET / ORAL2006-06-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076052-005SIMVASTATIN80MGTABLET / ORAL2006-12-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076052-001SIMVASTATIN5MGTABLET / ORAL2006-06-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076052-002SIMVASTATIN10MGTABLET / ORAL2006-06-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076052-003SIMVASTATIN20MGTABLET / ORAL2006-06-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076052-004SIMVASTATIN40MGTABLET / ORAL2006-06-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076052-005SIMVASTATIN80MGTABLET / ORAL2006-12-202680178bc6a6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-070-90EA - Each71205-07001a23710-bd72-436f-a796-54c54560638412018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-070SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]2Legacy NDC20191030_4615c9f1-04f5-4eb7-9a8d-cbb703772adb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-070-307120500703030 TABLET, FILM COATED in 1 BOTTLE (71205-070-30) 2018-07-020000-00-00NoNoCurrent
71205-070-607120500706060 TABLET, FILM COATED in 1 BOTTLE (71205-070-60) 2018-07-020000-00-00NoNoCurrent
71205-070-907120500709090 TABLET, FILM COATED in 1 BOTTLE (71205-070-90) 2018-07-020000-00-00NoNoCurrent