ATORVASTATIN CALCIUM

Product NDC
51407-080
Requested package NDC
51407-080-90
11-digit product format
514070080
Labeler code
51407
Product ID
51407-080_dd824969-e57c-631d-e053-2995a90ae173
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA205519
Marketing category
ANDA
Marketing start
2016-05-19
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51407-08051407-080-90DDiscontinued by firm2026-10-05

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51407-08051407-080-90DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51407-08051407-080-90DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A205519-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-05-19
A205519-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-05-19
A205519-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-05-19
A205519-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2016-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205519-001AB
A205519-002AB
A205519-003AB
A205519-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A205519-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-05-1984e616aacf4f…
2026-09-14 22:38:342026-08A205519-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-05-1984e616aacf4f…
2026-09-14 22:38:342026-08A205519-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-05-1984e616aacf4f…
2026-09-14 22:38:342026-08A205519-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2016-05-1984e616aacf4f…
2026-08-18 06:07:402026-07A205519-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07A205519-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07A205519-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07A205519-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2016-05-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205519-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205519-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205519-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205519-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2016-05-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205519-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205519-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205519-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205519-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2016-05-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A205519-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205519-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205519-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205519-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2016-05-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205519-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205519-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205519-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205519-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2016-05-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205519-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205519-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205519-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205519-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2016-05-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205519-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-05-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205519-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-05-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205519-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-05-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205519-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2016-05-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205519-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-05-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205519-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-05-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205519-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-05-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205519-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2016-05-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205519-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2016-05-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205519-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2016-05-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205519-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2016-05-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205519-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2016-05-195bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A205519-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A205519-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A205519-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A205519-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A205519-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205519-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205519-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205519-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205519-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205519-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205519-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205519-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205519-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205519-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205519-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205519-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205519-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205519-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205519-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205519-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205519-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205519-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205519-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205519-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205519-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205519-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205519-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205519-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205519-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205519-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205519-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205519-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205519-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205519-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205519-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205519-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205519-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205519-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205519-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205519-004AB15bbf6a4d5a75…

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
51407-080-10EA - Each51407-080ec68de92-3052-4dfe-b220-4dfadbc245c412018-10-11
51407-080-90EA - Each51407-08063c45ff0-50ec-45af-abe4-708f5347b89612018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-080ATORVASTATIN CALCIUM TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]12Legacy NDC20241027_75a0d6b3-7a5d-3458-e053-2a91aa0a702e.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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.f2d8b5e9-6ff2-4efa-ab01-e13df29f73712026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205519
application number: ANDA205519
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMRadha Pharmaceuticals, Inc.10e766cc-c3fd-4584-a0d7-652c516e828c2026-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205519
application number: ANDA205519
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch Prepackd1b9e56b-1632-4450-b1ca-d8bcbba3fd7c2026-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205519
application number: ANDA205519
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch Prepacke873d38c-4bda-4101-be98-85b1601d09f72026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205519
application number: ANDA205519
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch Prepack1914264b-4c95-4066-91ca-b5c91d8b741e2026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205519
application number: ANDA205519
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch Prepack5b9a5a36-7814-4d19-b146-01e819676ae22026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205519
application number: ANDA205519
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMCoupler LLC47cd0227-90a5-cdf6-e063-6294a90af6612026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205519
application number: ANDA205519
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch Prepack44a39b5a-77b6-42e8-9319-df21d3678e022025-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205519
application number: ANDA205519
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch Prepack635addf1-2024-4675-8d3c-380dc4548fbd2025-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205519
application number: ANDA205519
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch Prepack66df5c0b-be89-4fc7-8f8d-c7689952c6622025-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205519
application number: ANDA205519
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch Prepack271409d0-5500-4ed0-8730-5a93226a21912025-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205519
application number: ANDA205519
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.51f23212-a10d-4cfa-e054-00144ff88e882025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205519
application number: ANDA205519
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLC3dbeae00-89ab-48a6-9e57-8048facb22942023-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205519
application number: ANDA205519
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMProficient Rx LPa34d3c72-ce91-47c7-86a1-f32caaed2c472022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205519
application number: ANDA205519
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCed8e76a5-6b40-47fe-9018-25bfe690a4dd2018-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205519
application number: ANDA205519
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMCipla USA Inc.,18fe5990-399d-416c-852f-e14974317b8b2018-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205519
application number: ANDA205519
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCb16b3805-7e60-447c-b3df-7a9392b63c992018-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205519
application number: ANDA205519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-080-905140700809090 TABLET, FILM COATED in 1 BOTTLE (51407-080-90) 2018-09-120000-00-00NoNoCurrent