atorvastatin calcium

Product NDC
82137-018
Requested package NDC
82137-018-01
11-digit product format
821370018
Labeler code
82137
Product ID
82137-018_4257c559-499e-3a38-e063-6394a90aa0c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lepu Pharmaceutical Technology Co., Ltd.
Application
ANDA216848
Marketing category
ANDA
Marketing start
2022-11-01
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A216848-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2022-11-03
A216848-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2022-11-03
A216848-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2022-11-03
A216848-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2022-11-03

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 · 100 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216848-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2022-11-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216848-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2022-11-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216848-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2022-11-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216848-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2022-11-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216848-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2022-11-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216848-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2022-11-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216848-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2022-11-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216848-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2022-11-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A216848-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2022-11-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216848-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2022-11-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216848-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2022-11-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216848-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2022-11-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216848-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2022-11-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216848-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2022-11-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216848-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2022-11-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216848-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2022-11-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216848-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2022-11-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216848-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2022-11-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216848-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2022-11-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216848-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2022-11-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216848-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2022-11-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216848-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2022-11-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216848-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2022-11-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216848-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2022-11-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216848-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2022-11-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216848-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2022-11-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216848-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2022-11-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216848-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2022-11-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216848-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2022-11-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216848-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2022-11-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216848-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2022-11-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216848-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2022-11-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216848-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2022-11-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216848-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2022-11-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216848-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2022-11-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216848-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2022-11-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216848-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2022-11-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A216848-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2022-11-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A216848-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2022-11-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A216848-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2022-11-03d06236e962d9…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-05-13 08:27 UTC2023-05A216848-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A216848-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A216848-003AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A216848-004AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A216848-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A216848-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A216848-003AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A216848-004AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A216848-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A216848-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A216848-003AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A216848-004AB13a93d1ddd44b…

Additional Listing Data#

Finished product
Yes
Brand name base
atorvastatin calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE40 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
173474b6-26b4-46f2-a12a-64753ae5e905Available 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
82137-018-01atorvastatin calcium90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82137-018ATORVASTATIN CALCIUM TABLET, FILM COATED [LEPU PHARMACEUTICAL TECHNOLOGY CO., LTD.]7Current NDC, Legacy NDC, 1 package rows20241106_173474b6-26b4-46f2-a12a-64753ae5e905.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
atorvastatin calciumATORVASTATIN CALCIUMLepu Pharmaceutical Technology Co., Ltd.173474b6-26b4-46f2-a12a-64753ae5e9052025-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216848
application number: ANDA216848
ndc (package): 82137-018-01
ndc (product): 82137-018
ndc11 (package): 82137001801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN173474b6-26b4-46f2-a12a-64753ae5e9058
617310atorvastatin calcium 20 MG Oral TabletPSN173474b6-26b4-46f2-a12a-64753ae5e9058
617311atorvastatin calcium 40 MG Oral TabletPSN173474b6-26b4-46f2-a12a-64753ae5e9058
259255atorvastatin calcium 80 MG Oral TabletPSN173474b6-26b4-46f2-a12a-64753ae5e9058
617312atorvastatin 10 MG Oral TabletSCD173474b6-26b4-46f2-a12a-64753ae5e9058
617310atorvastatin 20 MG Oral TabletSCD173474b6-26b4-46f2-a12a-64753ae5e9058
617311atorvastatin 40 MG Oral TabletSCD173474b6-26b4-46f2-a12a-64753ae5e9058
259255atorvastatin 80 MG Oral TabletSCD173474b6-26b4-46f2-a12a-64753ae5e9058
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY173474b6-26b4-46f2-a12a-64753ae5e9058
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY173474b6-26b4-46f2-a12a-64753ae5e9058
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY173474b6-26b4-46f2-a12a-64753ae5e9058
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY173474b6-26b4-46f2-a12a-64753ae5e9058

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82137-018-018213700180190 TABLET, FILM COATED in 1 BOTTLE (82137-018-01) 2022-11-010000-00-00NoNoCurrent