AMLODIPINE AND ATORVASTATIN Tablets

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:48:37

Label at a glance#

ProductAmlodipine and atorvastatin
Active ingredientAMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1457-3

Amlodipine and atorvastatin tablets USP, 2.5 mg/ 10 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1458-3

Amlodipine and atorvastatin tablets USP, 2.5 mg/ 20 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1459-3

Amlodipine and atorvastatin tablets USP, 2.5 mg/ 40 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1460-3

Amlodipine and atorvastatin tablets USP, 5 mg/ 10 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1461-3

Amlodipine and atorvastatin tablets USP, 5 mg/ 20 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1462-3

Amlodipine and atorvastatin tablets USP, 5 mg/ 40 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1463-3

Amlodipine and atorvastatin tablets USP, 5 mg/ 80 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1464-3

Amlodipine and atorvastatin tablets USP, 10 mg/ 10 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1465-3

Amlodipine and atorvastatin tablets USP, 10 mg/ 20 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1466-3

Amlodipine and atorvastatin tablets USP, 10 mg/ 40 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1467-3

Amlodipine and atorvastatin tablets USP, 10 mg/80 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
Amlodipine and Atorvastatin Tablets, USP

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 4 · 147 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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…

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
a4b8d2f0-8040-4849-ae37-9120ab5c3ab3337b47f6-d4df-48ed-b19f-96fcbae3884b2025-03-21Exact identifier
spl set id: 337b47f6-d4df-48ed-b19f-96fcbae3884b

Reported adverse events (FAERS/openFDA)#

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