Atorvastatin Calcium

Product NDC
70377-078
11-digit product format
703770078
Labeler code
70377
Product ID
70377-078_72b8b3f5-4658-80af-655c-87ce7966a5e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Biocon Pharma Inc.
Application
ANDA216436
Marketing category
ANDA
Marketing start
2023-03-01
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
2026-12-31
Current FDA listing
Yes

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
A216436-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2022-11-23
A216436-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2022-11-23
A216436-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2022-11-23
A216436-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2022-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216436-001AB
A216436-002AB
A216436-003AB
A216436-004AB

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 3 · 104 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A216436-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2022-11-2384e616aacf4f…
2026-09-14 22:38:342026-08A216436-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2022-11-2384e616aacf4f…
2026-09-14 22:38:342026-08A216436-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2022-11-2384e616aacf4f…
2026-09-14 22:38:342026-08A216436-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2022-11-2384e616aacf4f…
2026-08-18 06:07:402026-07A216436-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2022-11-23caaa826d4ba7…
2026-08-18 06:07:402026-07A216436-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2022-11-23caaa826d4ba7…
2026-08-18 06:07:402026-07A216436-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2022-11-23caaa826d4ba7…
2026-08-18 06:07:402026-07A216436-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2022-11-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216436-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2022-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216436-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2022-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216436-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2022-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216436-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2022-11-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216436-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2022-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216436-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2022-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216436-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2022-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216436-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2022-11-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A216436-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2022-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216436-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2022-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216436-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2022-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216436-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2022-11-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216436-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2022-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216436-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2022-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216436-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2022-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216436-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2022-11-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216436-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2022-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216436-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2022-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216436-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2022-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216436-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2022-11-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216436-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2022-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216436-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2022-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216436-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2022-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216436-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2022-11-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216436-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2022-11-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216436-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2022-11-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216436-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2022-11-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216436-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2022-11-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216436-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2022-11-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216436-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2022-11-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216436-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2022-11-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216436-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2022-11-235bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A216436-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A216436-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A216436-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A216436-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A216436-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216436-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216436-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216436-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216436-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216436-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216436-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216436-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216436-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216436-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216436-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216436-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216436-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216436-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216436-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216436-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216436-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216436-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216436-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216436-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216436-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216436-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216436-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216436-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216436-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216436-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216436-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216436-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216436-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216436-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216436-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216436-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216436-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216436-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216436-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216436-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Atorvastatin Calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
48A5M73Z4QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
259255Internal RxNorm lookup
617310Internal RxNorm lookup
617311Internal RxNorm lookup
617312Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5b839619-1805-c227-91bf-182f5b966ba4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70377-078-11Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED9010
70377-078-12Atorvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED50010
70377-078-13Atorvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-078-11EA - Each70377-0783c7c8b16-95b2-4139-8557-285e95e6631312024-02-14
70377-078-13EA - Each70377-078d39f7909-9243-4e2a-8320-a298c6a4375a12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-078ATORVASTATIN CALCIUM TABLET, FILM COATED [BIOCON PHARMA INC.]10Current NDC, 3 package rows20250306_5b839619-1805-c227-91bf-182f5b966ba4.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
Atorvastatin CalciumATORVASTATIN CALCIUMSt. Mary's Medical Park Pharmacy149322ec-9ee6-2223-e063-6294a90a8aac2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216436
application number: ANDA216436
Atorvastatin CalciumATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.6e6a3b6b-5536-434e-bd1d-7dc7256704ce2026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216436
application number: ANDA216436
Atorvastatin CalciumATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.2d9cb8d9-b367-464d-9bcd-6de8de2b6c232026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216436
application number: ANDA216436
Atorvastatin CalciumATORVASTATIN CALCIUMBiocon Pharma Inc.5b839619-1805-c227-91bf-182f5b966ba42025-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216436
application number: ANDA216436
ndc (product): 70377-078
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.16c59ba4-1cb7-e23f-e063-6294a90a16832024-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216436
application number: ANDA216436
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.12751ca4-cde3-92dd-e063-6294a90a4e9d2024-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216436
application number: ANDA216436
Atorvastatin CalciumATORVASTATIN CALCIUMProficient Rx LPf3af6315-08b5-4ff9-80ae-2984f05986112023-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216436
application number: ANDA216436

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN5b839619-1805-c227-91bf-182f5b966ba410
617310atorvastatin calcium 20 MG Oral TabletPSN5b839619-1805-c227-91bf-182f5b966ba410
617311atorvastatin calcium 40 MG Oral TabletPSN5b839619-1805-c227-91bf-182f5b966ba410
259255atorvastatin calcium 80 MG Oral TabletPSN5b839619-1805-c227-91bf-182f5b966ba410
617312atorvastatin 10 MG Oral TabletSCD5b839619-1805-c227-91bf-182f5b966ba410
617310atorvastatin 20 MG Oral TabletSCD5b839619-1805-c227-91bf-182f5b966ba410
617311atorvastatin 40 MG Oral TabletSCD5b839619-1805-c227-91bf-182f5b966ba410
259255atorvastatin 80 MG Oral TabletSCD5b839619-1805-c227-91bf-182f5b966ba410
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY5b839619-1805-c227-91bf-182f5b966ba410
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY5b839619-1805-c227-91bf-182f5b966ba410
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY5b839619-1805-c227-91bf-182f5b966ba410
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY5b839619-1805-c227-91bf-182f5b966ba410
617310atorvastatin calcium 20 MG Oral TabletPSN6e6a3b6b-5536-434e-bd1d-7dc7256704ce3
617310atorvastatin 20 MG Oral TabletSCD6e6a3b6b-5536-434e-bd1d-7dc7256704ce3
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY6e6a3b6b-5536-434e-bd1d-7dc7256704ce3
617310atorvastatin calcium 20 MG Oral TabletPSNf3af6315-08b5-4ff9-80ae-2984f05986111
617310atorvastatin calcium 20 MG Oral TabletPSN261b6b9c-b85e-2fc1-e063-6294a90a258a1
617310atorvastatin calcium 20 MG Oral TabletPSN12751ca4-cde3-92dd-e063-6294a90a4e9d1
617310atorvastatin 20 MG Oral TabletSCD261b6b9c-b85e-2fc1-e063-6294a90a258a1
617310atorvastatin 20 MG Oral TabletSCDf3af6315-08b5-4ff9-80ae-2984f05986111
617310atorvastatin 20 MG Oral TabletSCD12751ca4-cde3-92dd-e063-6294a90a4e9d1
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY261b6b9c-b85e-2fc1-e063-6294a90a258a1
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY12751ca4-cde3-92dd-e063-6294a90a4e9d1
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYf3af6315-08b5-4ff9-80ae-2984f05986111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70377-078-117037700781190 TABLET, FILM COATED in 1 BOTTLE (70377-078-11) 2023-03-01NoNoCurrent
70377-078-1270377007812500 TABLET, FILM COATED in 1 BOTTLE (70377-078-12) 2023-03-01NoNoCurrent
70377-078-13703770078131000 TABLET, FILM COATED in 1 BOTTLE (70377-078-13) 2023-03-01NoNoCurrent