Atorvastatin Calcium

Product NDC
70934-296
11-digit product format
709340296
Labeler code
70934
Product ID
70934-296_d218f365-6f4a-5639-e053-2995a90a10a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA076477
Marketing category
ANDA
Marketing start
2011-12-01
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
20 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70934-296DDiscontinued by firm2026-08-17
excluded packagepackage70934-29670934-296-30DDiscontinued by firm2026-08-17
excluded packagepackage70934-29670934-296-96DDiscontinued 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 · 36 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 packagepackage70934-296-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-296-96d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-296-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-296-96f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-296-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-296-962ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-296-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-296-96a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-296-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-296-96cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-296-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-296-96cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-296-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-296-96302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70934-296-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70934-296-96ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70934-296-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70934-296-960efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70934-296-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70934-296-96ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70934-296-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70934-296-96367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70934-296-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70934-296-96557ba5c1ecfa…9c80585c8c6e…

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

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
A076477-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-30
A076477-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-30
A076477-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-30
A076477-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-30

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-30d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076477-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076477-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076477-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076477-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076477-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076477-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076477-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076477-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076477-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076477-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076477-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076477-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076477-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076477-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076477-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076477-004AB11e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-296-30EA - Each70934-2967c2a311f-fb61-43cb-877f-c8b27f96201612022-11-07

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
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepack2e583569-499d-4f20-87ca-84e7d9868d222026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMSun Pharmaceutical Industries Inc.595ab888-6b55-4642-a32f-e8521821ed812026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.49dcc58a-9f23-045d-e063-6394a90abda62026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDIRECT RXc3b70f79-45a3-0869-e053-2a95a90a3cdb2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepackf7af3b3a-b73e-41ee-80e3-2be036672bb72024-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.b1a840cf-47aa-b931-e053-2a95a90a10472024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepackbbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f2024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMProficient Rx LPd77e155c-403d-449e-bafd-11c9bd4974dd2020-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-296-307093402963030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-296-30) 2019-02-270000-00-00NoNoCurrent
70934-296-9670934029696180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-296-96) 2019-06-130000-00-00NoNoCurrent