Amlodipine and atorvastatin

Product NDC: 0378-4513
11-digit product format: 003784513
Labeler code: 0378
Product ID: 0378-4513_bee991e8-1686-425f-95cb-ff8d3133fffa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine and atorvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA200465
Marketing category: ANDA
Marketing start: 2015-04-02
Substance: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 5; 10 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 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
A200465-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL		2013-11-29
A200465-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL		2013-11-29
A200465-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL		2013-11-29
A200465-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2013-11-29
A200465-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2013-11-29
A200465-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2013-11-29
A200465-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2013-11-29
A200465-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2013-11-29
A200465-009	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2013-11-29
A200465-010	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2013-11-29
A200465-011	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2013-11-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
A200465-004	AB
A200465-005	AB
A200465-006	AB
A200465-007	AB
A200465-008	AB
A200465-009	AB
A200465-010	AB
A200465-011	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	A200465-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL		2013-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200465-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL		2013-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200465-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL		2013-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200465-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2013-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200465-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2013-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200465-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2013-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200465-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2013-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200465-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2013-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200465-009	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2013-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200465-010	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2013-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200465-011	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2013-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL		2013-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL		2013-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL		2013-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2013-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2013-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2013-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2013-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2013-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-009	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2013-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-010	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2013-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-011	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2013-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200465-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL		2013-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200465-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL		2013-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200465-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL		2013-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200465-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2013-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200465-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2013-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200465-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2013-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200465-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2013-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200465-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2013-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200465-009	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2013-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200465-010	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2013-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200465-011	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2013-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200465-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL		2013-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200465-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL		2013-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200465-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL		2013-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200465-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2013-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200465-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2013-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200465-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2013-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200465-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2013-11-29	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 352 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	A200465-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200465-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200465-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200465-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200465-008	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200465-009	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200465-010	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200465-011	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-008	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-009	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-010	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200465-011	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200465-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200465-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200465-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200465-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200465-008	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200465-009	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200465-010	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200465-011	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200465-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200465-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200465-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200465-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200465-008	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200465-009	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200465-010	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200465-011	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200465-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200465-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200465-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200465-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200465-008	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200465-009	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200465-010	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200465-011	AB	1	`b8a1b40f171c…`

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	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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
404011	Internal RxNorm lookup
404013	Internal RxNorm lookup
597967	Internal RxNorm lookup
597977	Internal RxNorm lookup
597980	Internal RxNorm lookup
597984	Internal RxNorm lookup
597987	Internal RxNorm lookup
597990	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
4be76756-4114-4d50-a36c-fd410f6c773d	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
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1	Product name	1	20150316
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508
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
0378-4513-93	Amlodipine and atorvastatin	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-4513-05	EA - Each	0378-4513	c79246b6-af04-4483-ba24-ce5e9a2066f2	1	2014-05-02
0378-4513-93	EA - Each	0378-4513	525b5b32-8de7-4e97-a383-4153513a6430	1	2015-05-05

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 [MYLAN PHARMACEUTICALS INC.]	5
ATORVASTATIN CALCIUM TRIHYDRATE	ACTIVE INGREDIENT	48A5M73Z4Q	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
ATORVASTATIN	ACTIVE MOIETY	A0JWA85V8F	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
ARGININE	INACTIVE INGREDIENT	94ZLA3W45F	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-4513	AMLODIPINE AND ATORVASTATIN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	18	Current NDC, Legacy NDC, 1 package rows	20250321_4be76756-4114-4d50-a36c-fd410f6c773d.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 and atorvastatin	AMLODIPINE AND ATORVASTATIN	Mylan Pharmaceuticals Inc.	4be76756-4114-4d50-a36c-fd410f6c773d	2024-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200465 application number: ANDA200465 ndc (product): 0378-4513

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	4be76756-4114-4d50-a36c-fd410f6c773d	18
597967	amLODIPine besylate 10 MG / atorvastatin calcium 20 MG Oral Tablet	PSN	4be76756-4114-4d50-a36c-fd410f6c773d	18
597990	amLODIPine besylate 10 MG / atorvastatin calcium 40 MG Oral Tablet	PSN	4be76756-4114-4d50-a36c-fd410f6c773d	18
404013	amLODIPine besylate 10 MG / atorvastatin calcium 80 MG Oral Tablet	PSN	4be76756-4114-4d50-a36c-fd410f6c773d	18
597977	amLODIPine besylate 5 MG / atorvastatin calcium 10 MG Oral Tablet	PSN	4be76756-4114-4d50-a36c-fd410f6c773d	18
597980	amLODIPine besylate 5 MG / atorvastatin calcium 20 MG Oral Tablet	PSN	4be76756-4114-4d50-a36c-fd410f6c773d	18
597984	amLODIPine besylate 5 MG / atorvastatin calcium 40 MG Oral Tablet	PSN	4be76756-4114-4d50-a36c-fd410f6c773d	18
404011	amLODIPine besylate 5 MG / atorvastatin calcium 80 MG Oral Tablet	PSN	4be76756-4114-4d50-a36c-fd410f6c773d	18
597987	amlodipine 10 MG / atorvastatin 10 MG Oral Tablet	SCD	4be76756-4114-4d50-a36c-fd410f6c773d	18
597967	amlodipine 10 MG / atorvastatin 20 MG Oral Tablet	SCD	4be76756-4114-4d50-a36c-fd410f6c773d	18
597990	amlodipine 10 MG / atorvastatin 40 MG Oral Tablet	SCD	4be76756-4114-4d50-a36c-fd410f6c773d	18
404013	amlodipine 10 MG / atorvastatin 80 MG Oral Tablet	SCD	4be76756-4114-4d50-a36c-fd410f6c773d	18
597977	amlodipine 5 MG / atorvastatin 10 MG Oral Tablet	SCD	4be76756-4114-4d50-a36c-fd410f6c773d	18
597980	amlodipine 5 MG / atorvastatin 20 MG Oral Tablet	SCD	4be76756-4114-4d50-a36c-fd410f6c773d	18
597984	amlodipine 5 MG / atorvastatin 40 MG Oral Tablet	SCD	4be76756-4114-4d50-a36c-fd410f6c773d	18
404011	amlodipine 5 MG / atorvastatin 80 MG Oral Tablet	SCD	4be76756-4114-4d50-a36c-fd410f6c773d	18
597987	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	4be76756-4114-4d50-a36c-fd410f6c773d	18
597967	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	4be76756-4114-4d50-a36c-fd410f6c773d	18
597990	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	4be76756-4114-4d50-a36c-fd410f6c773d	18
404013	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	4be76756-4114-4d50-a36c-fd410f6c773d	18
597977	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	4be76756-4114-4d50-a36c-fd410f6c773d	18
597980	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	4be76756-4114-4d50-a36c-fd410f6c773d	18
597984	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	4be76756-4114-4d50-a36c-fd410f6c773d	18
404011	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	4be76756-4114-4d50-a36c-fd410f6c773d	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-4513-93	00378451393	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4513-93)	2015-04-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	2024-11-11	HUMAN PRESCRIPTION DRUG LABEL	18