Amlodipine and Atorvastatin

Product NDC: 46708-765
11-digit product format: 467080765
Labeler code: 46708
Product ID: 46708-765_ecab983e-6ed8-4440-b7b4-7ac4bf39b26c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine and Atorvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA217279
Marketing category: ANDA
Marketing start: 2025-05-23
Substance: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 10; 80 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: 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 · 11 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A217279-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2025-05-22
A217279-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2025-05-22
A217279-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2025-05-22
A217279-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2025-05-22
A217279-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2025-05-22
A217279-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2025-05-22
A217279-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2025-05-22
A217279-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2025-05-22
A217279-009	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2025-05-22
A217279-010	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2025-05-22
A217279-011	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2025-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217279-001	AB
A217279-002	AB
A217279-003	AB
A217279-004	AB
A217279-005	AB
A217279-006	AB
A217279-007	AB
A217279-008	AB
A217279-009	AB
A217279-010	AB
A217279-011	AB

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 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217279-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2025-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2025-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2025-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2025-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2025-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2025-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2025-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2025-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-009	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2025-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-010	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2025-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-011	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2025-05-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217279-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2025-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2025-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2025-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2025-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2025-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2025-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2025-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2025-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-009	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2025-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-010	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2025-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-011	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2025-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217279-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2025-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2025-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2025-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2025-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2025-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2025-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2025-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2025-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-009	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2025-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-010	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2025-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-011	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2025-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217279-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2025-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217279-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2025-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217279-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2025-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217279-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2025-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217279-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2025-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217279-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2025-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217279-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2025-05-22	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217279-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-008	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-009	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-010	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217279-011	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217279-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-008	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-009	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-010	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217279-011	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217279-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-008	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-009	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-010	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217279-011	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217279-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217279-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217279-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217279-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217279-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217279-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217279-007	AB	1	`31067a03dcf5…`

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: Amlodipine and Atorvastatin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMLODIPINE BESYLATE	10 mg/1
ATORVASTATIN CALCIUM TRIHYDRATE	80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
864V2Q084H	Internal UNII lookup
48A5M73Z4Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
404011	Internal RxNorm lookup
404013	Internal RxNorm lookup
597967	Internal RxNorm lookup
597971	Internal RxNorm lookup
597974	Internal RxNorm lookup
597977	Internal RxNorm lookup
597980	Internal RxNorm lookup
597984	Internal RxNorm lookup
597987	Internal RxNorm lookup
597990	Internal RxNorm lookup
597993	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa898d56-9495-d6f0-309b-68a5d8e3914a	Product name	4	20260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
265792b3-b999-c010-7364-a7db20b9d4d9	Product name	5	20250515
d25cba4b-d79e-4890-8837-1382f7d09489	Product name	1	20231002
91774e91-b249-45e3-8ff8-4b5db2927a69	Product name	1	20230718
14c2c15b-f823-4ada-a40e-a440544294dc	Product name	1	20221207
03fb3cda-d60a-4873-94e9-6fa77cfb1a1c	Product name	1	20220302
34152997-af0b-acf4-dcaf-37211afe8ca4	Product name	9	20210312
a72887ef-d675-499f-af4b-78688f6855cd	Product name	1	20191002
a4484670-2869-6416-f6ff-03b1b3cbd1b0	Product name	2	20190415
4a27501f-a987-48a5-99b4-e983d4744d76	Product name	7	20181211
18600d07-613d-bf9c-2711-fe40c06f3393	Product name	5	20180703
bded1554-44de-900a-5297-403365d6d4b2	Product name	3	20170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1	Product name	1	20150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81	Product name	1	20140508
63ab5fbf-2a6b-c41d-051a-39e845d718b1	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46708-765-30	Amlodipine and Atorvastatin	30 in 1 BOTTLE	TABLET, FILM COATED	30		1
46708-765-90	Amlodipine and Atorvastatin	90 in 1 BOTTLE	TABLET, FILM COATED	90		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-765	AMLODIPINE AND ATORVASTATIN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]	1	Current NDC, 2 package rows	20250528_ecab983e-6ed8-4440-b7b4-7ac4bf39b26c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine and Atorvastatin	AMLODIPINE AND ATORVASTATIN	Alembic Pharmaceuticals Inc.	1346631f-e6db-4c5c-a6af-5aa7b80a011d	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217279 application number: ANDA217279
Amlodipine and Atorvastatin	AMLODIPINE AND ATORVASTATIN	Alembic Pharmaceuticals Limited	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217279 application number: ANDA217279 ndc (product): 46708-765

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE
48A5M73Z4Q	ATORVASTATIN CALCIUM TRIHYDRATE	344423-98-9	ATORVASTATIN CALCIUM TRIHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
597987	amLODIPine besylate 10 MG / atorvastatin calcium 10 MG Oral Tablet	PSN	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597967	amLODIPine besylate 10 MG / atorvastatin calcium 20 MG Oral Tablet	PSN	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597990	amLODIPine besylate 10 MG / atorvastatin calcium 40 MG Oral Tablet	PSN	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
404013	amLODIPine besylate 10 MG / atorvastatin calcium 80 MG Oral Tablet	PSN	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597971	amLODIPine besylate 2.5 MG / atorvastatin calcium 10 MG Oral Tablet	PSN	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597974	amLODIPine besylate 2.5 MG / atorvastatin calcium 20 MG Oral Tablet	PSN	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597993	amLODIPine besylate 2.5 MG / atorvastatin calcium 40 MG Oral Tablet	PSN	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597977	amLODIPine besylate 5 MG / atorvastatin calcium 10 MG Oral Tablet	PSN	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597980	amLODIPine besylate 5 MG / atorvastatin calcium 20 MG Oral Tablet	PSN	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597984	amLODIPine besylate 5 MG / atorvastatin calcium 40 MG Oral Tablet	PSN	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
404011	amLODIPine besylate 5 MG / atorvastatin calcium 80 MG Oral Tablet	PSN	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597987	amlodipine 10 MG / atorvastatin 10 MG Oral Tablet	SCD	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597967	amlodipine 10 MG / atorvastatin 20 MG Oral Tablet	SCD	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597990	amlodipine 10 MG / atorvastatin 40 MG Oral Tablet	SCD	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
404013	amlodipine 10 MG / atorvastatin 80 MG Oral Tablet	SCD	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597971	amlodipine 2.5 MG / atorvastatin 10 MG Oral Tablet	SCD	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597974	amlodipine 2.5 MG / atorvastatin 20 MG Oral Tablet	SCD	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597993	amlodipine 2.5 MG / atorvastatin 40 MG Oral Tablet	SCD	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597977	amlodipine 5 MG / atorvastatin 10 MG Oral Tablet	SCD	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597980	amlodipine 5 MG / atorvastatin 20 MG Oral Tablet	SCD	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597984	amlodipine 5 MG / atorvastatin 40 MG Oral Tablet	SCD	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
404011	amlodipine 5 MG / atorvastatin 80 MG Oral Tablet	SCD	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597987	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597967	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597990	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
404013	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597971	amlodipine (as amlodipine besylate) 2.5 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597974	amlodipine (as amlodipine besylate) 2.5 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597993	amlodipine (as amlodipine besylate) 2.5 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597977	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597980	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
597984	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1
404011	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	ecab983e-6ed8-4440-b7b4-7ac4bf39b26c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
46708-765-30	46708076530	30 TABLET, FILM COATED in 1 BOTTLE (46708-765-30)	2025-05-23	No	No	Current
46708-765-90	46708076590	90 TABLET, FILM COATED in 1 BOTTLE (46708-765-90)	2025-05-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine and Atorvastatin	Alembic Pharmaceuticals Limited	2025-05-23	Human Prescription Drug Label	1