Amlodipine besylate and Atorvastatin calcium

Product NDC: 43598-322
Requested package NDC: 43598-322-05
11-digit product format: 435980322
Labeler code: 43598
Product ID: 43598-322_54058ac6-94e2-d2d3-5c46-886b3478fc76
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine besylate and Atorvastatin calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Dr. Reddy's Laboratories Inc
Application: ANDA203874
Marketing category: ANDA
Marketing start: 2014-03-17
Substance: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 5; 10 mg/1; mg/1
Pharmacologic classes: Calcium Channel Antagonists [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 1.

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
A203874-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2014-03-07
A203874-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2014-03-07
A203874-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2014-03-07
A203874-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2014-03-07
A203874-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2014-03-07
A203874-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2014-03-07
A203874-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2014-03-07
A203874-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2014-03-07
A203874-009	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2014-03-07
A203874-010	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2014-03-07
A203874-011	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2014-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203874-001	AB
A203874-002	AB
A203874-003	AB
A203874-004	AB
A203874-005	AB
A203874-006	AB
A203874-007	AB
A203874-008	AB
A203874-009	AB
A203874-010	AB
A203874-011	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 12 · 451 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
2026-02-19 14:30 UTC	2026-02	A203874-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2014-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2014-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2014-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2014-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2014-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2014-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2014-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2014-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-009	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2014-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-010	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2014-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-011	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2014-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2014-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2014-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2014-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2014-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2014-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2014-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2014-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2014-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-009	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2014-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-010	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2014-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-011	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2014-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203874-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2014-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2014-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2014-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2014-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2014-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2014-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2014-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2014-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-009	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2014-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-010	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2014-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-011	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2014-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203874-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2014-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203874-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2014-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203874-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2014-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203874-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2014-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203874-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2014-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203874-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2014-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203874-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2014-03-07	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 12 · 451 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203874-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-008	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-009	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-010	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203874-011	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-008	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-009	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-010	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203874-011	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203874-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-008	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-009	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-010	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203874-011	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203874-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203874-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203874-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203874-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203874-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203874-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203874-007	AB	1	`fd3edfee7708…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amlodipine besylate and Atorvastatin calcium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMLODIPINE BESYLATE	5 mg/1
ATORVASTATIN CALCIUM TRIHYDRATE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
48A5M73Z4Q	Internal UNII lookup
864V2Q084H	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
abee4a34-89cc-d886-192c-32582ab8f024	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
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
d25cba4b-d79e-4890-8837-1382f7d09489	Product name	1	20231002
91774e91-b249-45e3-8ff8-4b5db2927a69	Product name	1	20230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
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
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
a72887ef-d675-499f-af4b-78688f6855cd	Product name	1	20191002
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
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
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
bded1554-44de-900a-5297-403365d6d4b2	Product name	3	20170110
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1	Product name	1	20150316
89dac932-b90a-4410-9ab1-84c53e57de25	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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43598-322-05	Amlodipine besylate and Atorvastatin calcium	500 in 1 BOTTLE	TABLET, FILM COATED	500	16
43598-322-30	Amlodipine besylate and Atorvastatin calcium	30 in 1 BOTTLE	TABLET, FILM COATED	30	16
43598-322-60	Amlodipine besylate and Atorvastatin calcium	60 in 1 BOTTLE	TABLET, FILM COATED	60	16
43598-322-90	Amlodipine besylate and Atorvastatin calcium	90 in 1 BOTTLE	TABLET, FILM COATED	90	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-322-30	EA - Each	43598-322	232bc80e-9040-4e31-ad33-d9855c23e28a	1	2014-04-03
43598-322-90	EA - Each	43598-322	667a9d3a-2935-46c4-829c-87101c2d00d0	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
amlodipine besylate	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7
atorvastatin calcium	ACTIVE INGREDIENT	48A5M73Z4Q	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7
amlodipine	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7
atorvastatin	ACTIVE MOIETY	A0JWA85V8F	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7
crospovidone	INACTIVE INGREDIENT	68401960MK	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7
hydrogenated soybean lecithin	INACTIVE INGREDIENT	H1109Z9J4N	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7
Hydroxypropyl Cellulose (Type H)	INACTIVE INGREDIENT	RFW2ET671P	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7
polyethylene glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7
sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7
talc	INACTIVE INGREDIENT	7SEV7J4R1U	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-322	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]	16	Current NDC, Legacy NDC, 4 package rows	20210402_abee4a34-89cc-d886-192c-32582ab8f024.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine besylate and Atorvastatin calcium	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	Dr. Reddy's Laboratories Inc	abee4a34-89cc-d886-192c-32582ab8f024	2021-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203874 application number: ANDA203874 ndc (package): 43598-322-05 ndc (product): 43598-322 ndc11 (package): 43598032205

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	abee4a34-89cc-d886-192c-32582ab8f024	16
597967	amLODIPine besylate 10 MG / atorvastatin calcium 20 MG Oral Tablet	PSN	abee4a34-89cc-d886-192c-32582ab8f024	16
597990	amLODIPine besylate 10 MG / atorvastatin calcium 40 MG Oral Tablet	PSN	abee4a34-89cc-d886-192c-32582ab8f024	16
404013	amLODIPine besylate 10 MG / atorvastatin calcium 80 MG Oral Tablet	PSN	abee4a34-89cc-d886-192c-32582ab8f024	16
597971	amLODIPine besylate 2.5 MG / atorvastatin calcium 10 MG Oral Tablet	PSN	abee4a34-89cc-d886-192c-32582ab8f024	16
597974	amLODIPine besylate 2.5 MG / atorvastatin calcium 20 MG Oral Tablet	PSN	abee4a34-89cc-d886-192c-32582ab8f024	16
597993	amLODIPine besylate 2.5 MG / atorvastatin calcium 40 MG Oral Tablet	PSN	abee4a34-89cc-d886-192c-32582ab8f024	16
597977	amLODIPine besylate 5 MG / atorvastatin calcium 10 MG Oral Tablet	PSN	abee4a34-89cc-d886-192c-32582ab8f024	16
597980	amLODIPine besylate 5 MG / atorvastatin calcium 20 MG Oral Tablet	PSN	abee4a34-89cc-d886-192c-32582ab8f024	16
597984	amLODIPine besylate 5 MG / atorvastatin calcium 40 MG Oral Tablet	PSN	abee4a34-89cc-d886-192c-32582ab8f024	16
404011	amLODIPine besylate 5 MG / atorvastatin calcium 80 MG Oral Tablet	PSN	abee4a34-89cc-d886-192c-32582ab8f024	16
597987	amlodipine 10 MG / atorvastatin 10 MG Oral Tablet	SCD	abee4a34-89cc-d886-192c-32582ab8f024	16
597967	amlodipine 10 MG / atorvastatin 20 MG Oral Tablet	SCD	abee4a34-89cc-d886-192c-32582ab8f024	16
597990	amlodipine 10 MG / atorvastatin 40 MG Oral Tablet	SCD	abee4a34-89cc-d886-192c-32582ab8f024	16
404013	amlodipine 10 MG / atorvastatin 80 MG Oral Tablet	SCD	abee4a34-89cc-d886-192c-32582ab8f024	16
597971	amlodipine 2.5 MG / atorvastatin 10 MG Oral Tablet	SCD	abee4a34-89cc-d886-192c-32582ab8f024	16
597974	amlodipine 2.5 MG / atorvastatin 20 MG Oral Tablet	SCD	abee4a34-89cc-d886-192c-32582ab8f024	16
597993	amlodipine 2.5 MG / atorvastatin 40 MG Oral Tablet	SCD	abee4a34-89cc-d886-192c-32582ab8f024	16
597977	amlodipine 5 MG / atorvastatin 10 MG Oral Tablet	SCD	abee4a34-89cc-d886-192c-32582ab8f024	16
597980	amlodipine 5 MG / atorvastatin 20 MG Oral Tablet	SCD	abee4a34-89cc-d886-192c-32582ab8f024	16
597984	amlodipine 5 MG / atorvastatin 40 MG Oral Tablet	SCD	abee4a34-89cc-d886-192c-32582ab8f024	16
404011	amlodipine 5 MG / atorvastatin 80 MG Oral Tablet	SCD	abee4a34-89cc-d886-192c-32582ab8f024	16
597987	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	abee4a34-89cc-d886-192c-32582ab8f024	16
597967	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	abee4a34-89cc-d886-192c-32582ab8f024	16
597990	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	abee4a34-89cc-d886-192c-32582ab8f024	16
404013	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	abee4a34-89cc-d886-192c-32582ab8f024	16
597971	amlodipine (as amlodipine besylate) 2.5 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	abee4a34-89cc-d886-192c-32582ab8f024	16
597974	amlodipine (as amlodipine besylate) 2.5 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	abee4a34-89cc-d886-192c-32582ab8f024	16
597993	amlodipine (as amlodipine besylate) 2.5 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	abee4a34-89cc-d886-192c-32582ab8f024	16
597977	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	abee4a34-89cc-d886-192c-32582ab8f024	16
597980	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	abee4a34-89cc-d886-192c-32582ab8f024	16
597984	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	abee4a34-89cc-d886-192c-32582ab8f024	16
404011	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	abee4a34-89cc-d886-192c-32582ab8f024	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-322-05	43598032205	500 TABLET, FILM COATED in 1 BOTTLE (43598-322-05)	2014-03-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine besylate and Atorvastatin calcium	Dr. Reddy's Laboratories Inc \| Dr. Reddy's Laboratories Limited-FTO3	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	16