NORLIQVA

Product NDC: 46287-035
11-digit product format: 462870035
Labeler code: 46287
Product ID: 46287-035_63a6bb49-fb68-4351-be5f-a6b6e8f6b540
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine
Dosage form: SOLUTION
Route: ORAL
Labeler: CMP Pharma, Inc.
Application: NDA214439
Marketing category: NDA
Marketing start: 2022-04-15
Substance: AMLODIPINE
Active strength: 1 mg/mL
Pharmacologic classes: Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214439-001	NORLIQVA	AMLODIPINE BESYLATE	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD, RS	2022-02-24

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214439-001	11253474	2041-02-24	U-3309	Drug product	2022-02-28
N214439-001	11253474	2041-02-24	U-3310	Drug product	2022-02-28
N214439-001	11253474	2041-02-24	U-3311	Drug product	2022-02-28
N214439-001	11458095	2041-02-24	U-3309	Drug product	2022-10-05
N214439-001	11458095	2041-02-24	U-3310	Drug product	2022-10-05
N214439-001	11458095	2041-02-24	U-3311	Drug product	2022-10-05
N214439-001	11723866	2041-02-24	U-3309	Drug product	2023-08-18
N214439-001	11723866	2041-02-24	U-3310	Drug product	2023-08-18
N214439-001	11723866	2041-02-24	U-3311	Drug product	2023-08-18
N214439-001	12005141	2041-02-24	U-3309	Drug product	2024-06-28
N214439-001	12005141	2041-02-24	U-3310	Drug product	2024-06-28
N214439-001	12005141	2041-02-24	U-3311	Drug product	2024-06-28
N214439-001	12226528	2041-02-24	U-3309	Drug product	2025-02-27
N214439-001	12226528	2041-02-24	U-3310	Drug product	2025-02-27
N214439-001	12226528	2041-02-24	U-3311	Drug product	2025-02-27
N214439-001	12440441	2041-02-24	U-3309	Drug product	2025-10-23
N214439-001	12440441	2041-02-24	U-3310	Drug product	2025-10-23
N214439-001	12440441	2041-02-24	U-3311	Drug product	2025-10-23

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214439-001	NORLIQVA	EQ 1MG BASE/ML	SOLUTION / ORAL	RLD, RS	2022-02-24	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 304 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214439-001	11253474	2041-02-24	U-3309	Drug product	2022-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214439-001	11253474	2041-02-24	U-3310	Drug product	2022-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214439-001	11253474	2041-02-24	U-3311	Drug product	2022-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214439-001	11458095	2041-02-24	U-3309	Drug product	2022-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214439-001	11458095	2041-02-24	U-3310	Drug product	2022-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214439-001	11458095	2041-02-24	U-3311	Drug product	2022-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214439-001	11723866	2041-02-24	U-3309	Drug product	2023-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214439-001	11723866	2041-02-24	U-3311	Drug product	2023-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214439-001	11723866	2041-02-24	U-3310	Drug product	2023-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214439-001	12005141	2041-02-24	U-3311	Drug product	2024-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214439-001	12005141	2041-02-24	U-3309	Drug product	2024-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214439-001	12005141	2041-02-24	U-3310	Drug product	2024-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214439-001	12226528	2041-02-24	U-3309	Drug product	2025-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214439-001	12226528	2041-02-24	U-3310	Drug product	2025-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214439-001	12226528	2041-02-24	U-3311	Drug product	2025-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214439-001	12440441	2041-02-24	U-3309	Drug product	2025-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214439-001	12440441	2041-02-24	U-3311	Drug product	2025-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214439-001	12440441	2041-02-24	U-3310	Drug product	2025-10-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214439-001	11253474	2041-02-24	U-3309	Drug product	2022-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214439-001	11253474	2041-02-24	U-3310	Drug product	2022-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214439-001	11253474	2041-02-24	U-3311	Drug product	2022-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214439-001	11458095	2041-02-24	U-3309	Drug product	2022-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214439-001	11458095	2041-02-24	U-3310	Drug product	2022-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214439-001	11458095	2041-02-24	U-3311	Drug product	2022-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214439-001	11723866	2041-02-24	U-3309	Drug product	2023-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214439-001	11723866	2041-02-24	U-3311	Drug product	2023-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214439-001	11723866	2041-02-24	U-3310	Drug product	2023-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214439-001	12005141	2041-02-24	U-3311	Drug product	2024-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214439-001	12005141	2041-02-24	U-3309	Drug product	2024-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214439-001	12005141	2041-02-24	U-3310	Drug product	2024-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214439-001	12226528	2041-02-24	U-3309	Drug product	2025-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214439-001	12226528	2041-02-24	U-3310	Drug product	2025-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214439-001	12226528	2041-02-24	U-3311	Drug product	2025-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214439-001	12440441	2041-02-24	U-3309	Drug product	2025-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214439-001	12440441	2041-02-24	U-3311	Drug product	2025-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214439-001	12440441	2041-02-24	U-3310	Drug product	2025-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214439-001	11253474	2041-02-24	U-3309	Drug product	2022-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214439-001	11253474	2041-02-24	U-3310	Drug product	2022-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214439-001	11253474	2041-02-24	U-3311	Drug product	2022-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214439-001	11458095	2041-02-24	U-3309	Drug product	2022-10-05	`31067a03dcf5…`

Additional Listing Data#

Finished product: Yes
Brand name base: NORLIQVA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMLODIPINE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1J444QC288	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2599173	Internal RxNorm lookup
2599179	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
c1730a51-4383-4c61-a9a1-7e1326bd0abe	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
14c2c15b-f823-4ada-a40e-a440544294dc	Product name	1	20221207
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
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
46287-035-15	NORLIQVA	150 mL in 1 BOTTLE	Solution	150		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46287-035-15	ML - Milliliter	46287-035	59c62678-4f9a-4c76-9470-52125bd9a4b2	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46287-035	NORLIQVA (AMLODIPINE) SOLUTION [CMP PHARMA, INC.]	1	Current NDC, Legacy NDC, 1 package rows	20220416_c1730a51-4383-4c61-a9a1-7e1326bd0abe.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
NORLIQVA	AMLODIPINE	CMP Pharma, Inc.	614d974f-51c7-4b18-8171-39eb6e8d4c03	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214439 application number: NDA214439
NORLIQVA	AMLODIPINE	CMP Pharma, Inc.	c1730a51-4383-4c61-a9a1-7e1326bd0abe	2022-02-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214439 application number: NDA214439 ndc (product): 46287-035

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1J444QC288	AMLODIPINE	88150-42-9	AMLODIPINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2599173	amLODIPine 1 MG/mL Oral Solution	PSN	c1730a51-4383-4c61-a9a1-7e1326bd0abe	1
2599179	Norliqva 1 MG/mL Oral Solution	PSN	c1730a51-4383-4c61-a9a1-7e1326bd0abe	1
2599179	amlodipine 1 MG/ML Oral Solution [Norliqva]	SBD	c1730a51-4383-4c61-a9a1-7e1326bd0abe	1
2599173	amlodipine 1 MG/ML Oral Solution	SCD	c1730a51-4383-4c61-a9a1-7e1326bd0abe	1
2599173	amlodipine 1 MG (as amlodipine besylate 1.385 MG) per ML Oral Solution	SY	c1730a51-4383-4c61-a9a1-7e1326bd0abe	1
2599179	Norliqva 1 MG (as amlodipine besylate 1.385 MG) per 1 ML Oral Solution	SY	c1730a51-4383-4c61-a9a1-7e1326bd0abe	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46287-035-15	46287003515	150 mL in 1 BOTTLE (46287-035-15)	150 ml	2022-04-15	0000-00-00	No	No	Current