Amlodipine and Atorvastatin

Product NDC: 60505-3493
11-digit product format: 605053493
Labeler code: 60505
Product ID: 60505-3493_f3120a95-7f28-006c-6bf7-12c962071ed9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine and Atorvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA205199
Marketing category: ANDA
Marketing start: 2020-07-29
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 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205199-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2019-11-18
A205199-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2019-11-18
A205199-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2019-11-18
A205199-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2019-11-18
A205199-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2019-11-18
A205199-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2019-11-18
A205199-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2019-11-18
A205199-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2019-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205199-001	AB
A205199-002	AB
A205199-003	AB
A205199-004	AB
A205199-005	AB
A205199-006	AB
A205199-007	AB
A205199-008	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 8 · 304 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	A205199-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2019-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205199-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2019-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205199-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2019-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205199-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2019-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205199-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2019-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205199-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2019-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205199-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2019-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205199-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2019-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205199-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2019-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205199-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2019-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205199-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2019-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205199-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2019-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205199-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2019-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205199-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2019-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205199-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2019-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205199-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2019-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205199-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2019-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205199-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2019-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205199-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2019-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205199-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2019-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205199-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2019-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205199-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2019-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205199-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2019-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205199-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2019-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205199-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2019-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205199-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2019-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205199-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2019-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205199-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2019-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205199-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2019-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205199-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2019-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205199-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2019-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205199-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2019-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205199-001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2019-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205199-002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2019-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205199-003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2019-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205199-004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2019-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205199-005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	2019-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205199-006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	2019-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205199-007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	2019-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205199-008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	2019-11-18	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 304 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	A205199-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205199-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205199-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205199-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205199-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205199-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205199-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205199-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205199-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205199-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205199-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205199-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205199-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205199-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205199-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205199-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205199-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205199-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205199-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205199-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205199-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205199-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205199-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205199-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205199-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205199-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205199-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205199-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205199-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205199-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205199-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205199-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205199-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205199-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205199-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205199-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205199-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205199-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205199-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205199-008	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	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
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
4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	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
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
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
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
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
60505-3493-3	Amlodipine and Atorvastatin	30 in 1 BOTTLE	TABLET, FILM COATED	30		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-3493-3	EA - Each	60505-3493	e641e3db-38fd-4a05-aaff-05af5bcf6255	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-3493	AMLODIPINE AND ATORVASTATIN TABLET, FILM COATED [APOTEX CORP.]	8	Current NDC, Legacy NDC, 1 package rows	20250416_4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine and Atorvastatin	AMLODIPINE AND ATORVASTATIN	Bryant Ranch Prepack	bed1710f-edd9-488d-855b-603d50ee212c	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205199 application number: ANDA205199
Amlodipine and Atorvastatin	AMLODIPINE AND ATORVASTATIN	Bryant Ranch Prepack	ba6f6ab5-b65a-4486-b994-2d8bbbe650af	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205199 application number: ANDA205199
Amlodipine and Atorvastatin	AMLODIPINE AND ATORVASTATIN	Bryant Ranch Prepack	5d7ca186-f22b-465f-913b-c020240b2c66	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205199 application number: ANDA205199
Amlodipine and Atorvastatin	AMLODIPINE AND ATORVASTATIN	Bryant Ranch Prepack	50112e22-5a69-47c9-90cd-82bbacae7418	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205199 application number: ANDA205199
Amlodipine and Atorvastatin	AMLODIPINE AND ATORVASTATIN	Bryant Ranch Prepack	9654e50b-811a-4c89-b1ab-f48418b204c1	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205199 application number: ANDA205199
Amlodipine and Atorvastatin	AMLODIPINE AND ATORVASTATIN	Bryant Ranch Prepack	043c4742-081d-4bc4-bf27-dad92bb2dfbc	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205199 application number: ANDA205199
Amlodipine and Atorvastatin	AMLODIPINE AND ATORVASTATIN	Bryant Ranch Prepack	be709711-e7ee-403f-ad43-873761deee37	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205199 application number: ANDA205199
Amlodipine and Atorvastatin	AMLODIPINE AND ATORVASTATIN	Apotex Corp.	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205199 application number: ANDA205199 ndc (product): 60505-3493

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	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
597967	amLODIPine besylate 10 MG / atorvastatin calcium 20 MG Oral Tablet	PSN	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
597990	amLODIPine besylate 10 MG / atorvastatin calcium 40 MG Oral Tablet	PSN	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
404013	amLODIPine besylate 10 MG / atorvastatin calcium 80 MG Oral Tablet	PSN	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
597977	amLODIPine besylate 5 MG / atorvastatin calcium 10 MG Oral Tablet	PSN	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
597980	amLODIPine besylate 5 MG / atorvastatin calcium 20 MG Oral Tablet	PSN	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
597984	amLODIPine besylate 5 MG / atorvastatin calcium 40 MG Oral Tablet	PSN	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
404011	amLODIPine besylate 5 MG / atorvastatin calcium 80 MG Oral Tablet	PSN	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
597987	amlodipine 10 MG / atorvastatin 10 MG Oral Tablet	SCD	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
597967	amlodipine 10 MG / atorvastatin 20 MG Oral Tablet	SCD	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
597990	amlodipine 10 MG / atorvastatin 40 MG Oral Tablet	SCD	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
404013	amlodipine 10 MG / atorvastatin 80 MG Oral Tablet	SCD	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
597977	amlodipine 5 MG / atorvastatin 10 MG Oral Tablet	SCD	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
597980	amlodipine 5 MG / atorvastatin 20 MG Oral Tablet	SCD	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
597984	amlodipine 5 MG / atorvastatin 40 MG Oral Tablet	SCD	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
404011	amlodipine 5 MG / atorvastatin 80 MG Oral Tablet	SCD	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
597987	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
597967	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
597990	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
404013	amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
597977	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
597980	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
597984	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10
404011	amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-3493-3	60505349303	30 TABLET, FILM COATED in 1 BOTTLE (60505-3493-3)	2020-07-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine and Atorvastatin	Apotex Corp. \| Apotex Inc.	2025-10-20	HUMAN PRESCRIPTION DRUG LABEL	10