Amlodipine and atorvastatin

Product NDC
70771-1458
Requested package NDC
70771-1458-1
11-digit product format
707711458
Labeler code
70771
Product ID
70771-1458_a4beebf9-4f71-45f0-8707-9273c8f02097
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and atorvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA207762
Marketing category
ANDA
Marketing start
2019-05-30
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
3 mg/1; mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], 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 packagepackage70771-145870771-1458-1DDiscontinued 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 packagepackage70771-145870771-1458-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70771-145870771-1458-1DDiscontinued 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 · 11 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207762-001AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 10MG BASETABLET / ORALAB2019-01-11
A207762-002AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 20MG BASETABLET / ORALAB2019-01-11
A207762-003AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 40MG BASETABLET / ORALAB2019-01-11
A207762-004AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 10MG BASETABLET / ORALAB2019-01-11
A207762-005AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 20MG BASETABLET / ORALAB2019-01-11
A207762-006AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 40MG BASETABLET / ORALAB2019-01-11
A207762-007AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 80MG BASETABLET / ORALAB2019-01-11
A207762-008AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 10MG BASETABLET / ORALAB2019-01-11
A207762-009AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 20MG BASETABLET / ORALAB2019-01-11
A207762-010AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 40MG BASETABLET / ORALAB2019-01-11
A207762-011AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMAMLODIPINE BESYLATE; ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 80MG BASETABLET / ORALAB2019-01-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 11 matching rows.

Application-product, TE code table
Application-productTE code
A207762-001AB
A207762-002AB
A207762-003AB
A207762-004AB
A207762-005AB
A207762-006AB
A207762-007AB
A207762-008AB
A207762-009AB
A207762-010AB
A207762-011AB

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 12 · 473 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207762-001AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 10MG BASETABLET / ORALAB2019-01-1184e616aacf4f…
2026-09-14 22:38:342026-08A207762-002AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 20MG BASETABLET / ORALAB2019-01-1184e616aacf4f…
2026-09-14 22:38:342026-08A207762-003AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 40MG BASETABLET / ORALAB2019-01-1184e616aacf4f…
2026-09-14 22:38:342026-08A207762-004AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 10MG BASETABLET / ORALAB2019-01-1184e616aacf4f…
2026-09-14 22:38:342026-08A207762-005AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 20MG BASETABLET / ORALAB2019-01-1184e616aacf4f…
2026-09-14 22:38:342026-08A207762-006AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 40MG BASETABLET / ORALAB2019-01-1184e616aacf4f…
2026-09-14 22:38:342026-08A207762-007AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 80MG BASETABLET / ORALAB2019-01-1184e616aacf4f…
2026-09-14 22:38:342026-08A207762-008AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 10MG BASETABLET / ORALAB2019-01-1184e616aacf4f…
2026-09-14 22:38:342026-08A207762-009AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 20MG BASETABLET / ORALAB2019-01-1184e616aacf4f…
2026-09-14 22:38:342026-08A207762-010AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 40MG BASETABLET / ORALAB2019-01-1184e616aacf4f…
2026-09-14 22:38:342026-08A207762-011AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 80MG BASETABLET / ORALAB2019-01-1184e616aacf4f…
2026-08-18 06:07:402026-07A207762-001AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 10MG BASETABLET / ORALAB2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-002AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 20MG BASETABLET / ORALAB2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-003AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 40MG BASETABLET / ORALAB2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-004AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 10MG BASETABLET / ORALAB2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-005AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 20MG BASETABLET / ORALAB2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-006AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 40MG BASETABLET / ORALAB2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-007AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 80MG BASETABLET / ORALAB2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-008AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 10MG BASETABLET / ORALAB2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-009AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 20MG BASETABLET / ORALAB2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-010AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 40MG BASETABLET / ORALAB2019-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-011AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 80MG BASETABLET / ORALAB2019-01-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207762-001AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 10MG BASETABLET / ORALAB2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-002AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 20MG BASETABLET / ORALAB2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-003AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 40MG BASETABLET / ORALAB2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-004AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 10MG BASETABLET / ORALAB2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-005AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 20MG BASETABLET / ORALAB2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-006AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 40MG BASETABLET / ORALAB2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-007AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 80MG BASETABLET / ORALAB2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-008AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 10MG BASETABLET / ORALAB2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-009AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 20MG BASETABLET / ORALAB2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-010AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 40MG BASETABLET / ORALAB2019-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-011AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 10MG BASE;EQ 80MG BASETABLET / ORALAB2019-01-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207762-001AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 10MG BASETABLET / ORALAB2019-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207762-002AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 20MG BASETABLET / ORALAB2019-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207762-003AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 2.5MG BASE;EQ 40MG BASETABLET / ORALAB2019-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207762-004AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 10MG BASETABLET / ORALAB2019-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207762-005AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 20MG BASETABLET / ORALAB2019-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207762-006AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 40MG BASETABLET / ORALAB2019-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207762-007AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMEQ 5MG BASE;EQ 80MG BASETABLET / ORALAB2019-01-1131067a03dcf5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 11 · 429 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A207762-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A207762-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A207762-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A207762-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A207762-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A207762-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A207762-007AB184e616aacf4f…
2026-09-14 22:38:342026-08A207762-008AB184e616aacf4f…
2026-09-14 22:38:342026-08A207762-009AB184e616aacf4f…
2026-09-14 22:38:342026-08A207762-010AB184e616aacf4f…
2026-09-14 22:38:342026-08A207762-011AB184e616aacf4f…
2026-08-18 06:07:402026-07A207762-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-008AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-009AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-010AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207762-011AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207762-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-008AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-009AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-010AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207762-011AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207762-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207762-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207762-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207762-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207762-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207762-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207762-007AB131067a03dcf5…

Reported adverse events (FAERS/openFDA)#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1458-170771145801100 TABLET, FILM COATED in 1 BOTTLE (70771-1458-1) 2019-05-300000-00-00NoNoCurrent