Norvasc

Product NDC: 21695-151
11-digit product format: 216950151
Labeler code: 21695
Product ID: 21695-151_b00570ff-4081-4514-b45b-eb6f753450f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine besylate
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA019787
Marketing category: NDA
Marketing start: 1992-07-31
Marketing end: 0000-00-00
Substance: AMLODIPINE BESYLATE
Active strength: 5 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-151		I	Inactivated by FDA		2026-08-17
excluded package	package	21695-151	21695-151-15	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-151-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-151-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-151-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-151-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-151-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-151-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-151-15	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-151-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-151-15	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-151-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-151-15	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-151-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-151-15	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-151-15	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-151-15	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-151-15	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-151-15	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-151-15	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-151-15	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-151-15	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-151-15	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-151-15	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019787-001	NORVASC	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31
N019787-002	NORVASC	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31
N019787-003	NORVASC	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1992-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N019787-001	AB
N019787-002	AB
N019787-003	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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019787-001	NORVASC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019787-002	NORVASC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019787-003	NORVASC	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1992-07-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019787-001	NORVASC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019787-002	NORVASC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019787-003	NORVASC	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1992-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019787-001	NORVASC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019787-002	NORVASC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019787-003	NORVASC	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1992-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019787-001	NORVASC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019787-002	NORVASC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019787-003	NORVASC	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1992-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019787-001	NORVASC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019787-002	NORVASC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019787-003	NORVASC	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1992-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019787-001	NORVASC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019787-002	NORVASC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019787-003	NORVASC	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1992-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019787-001	NORVASC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019787-002	NORVASC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019787-003	NORVASC	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1992-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019787-001	NORVASC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019787-002	NORVASC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019787-003	NORVASC	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1992-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019787-001	NORVASC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019787-002	NORVASC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019787-003	NORVASC	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1992-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019787-001	NORVASC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019787-002	NORVASC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019787-003	NORVASC	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1992-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019787-001	NORVASC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019787-002	NORVASC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019787-003	NORVASC	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1992-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019787-001	NORVASC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019787-002	NORVASC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019787-003	NORVASC	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1992-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019787-001	NORVASC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019787-002	NORVASC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019787-003	NORVASC	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1992-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019787-001	NORVASC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N019787-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019787-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019787-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019787-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019787-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019787-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019787-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019787-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019787-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019787-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019787-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019787-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019787-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019787-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019787-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019787-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019787-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019787-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019787-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019787-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019787-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019787-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019787-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019787-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019787-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019787-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019787-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019787-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019787-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019787-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019787-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019787-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019787-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019787-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019787-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019787-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019787-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019787-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019787-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019787-001	AB	1	`1e350fbaab3a…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-151-15	2019-09-24	C162847	48780-1	934fe258-4779-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use NORVASC safely and effectively. See full prescribing information for NORVASC. NORVASC ® (amlodipine besylate) Tablets for oral administration Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-151-15	Norvasc	15 in 1 BOTTLE	TABLET	15		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-151-15	EA - Each	21695-151	92cdc86c-83f1-4e61-944f-70612e605f56	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
amlodipine besylate	ACTIVE INGREDIENT	864V2Q084H	NORVASC (AMLODIPINE BESYLATE) TABLET [REBEL DISTRIBUTORS CORP]	1
Amlodipine	ACTIVE MOIETY	1J444QC288	NORVASC (AMLODIPINE BESYLATE) TABLET [REBEL DISTRIBUTORS CORP]	1
anhydrous dibasic calcium phosphate	INACTIVE INGREDIENT	L11K75P92J	NORVASC (AMLODIPINE BESYLATE) TABLET [REBEL DISTRIBUTORS CORP]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	NORVASC (AMLODIPINE BESYLATE) TABLET [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	NORVASC (AMLODIPINE BESYLATE) TABLET [REBEL DISTRIBUTORS CORP]	1
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	NORVASC (AMLODIPINE BESYLATE) TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-151	NORVASC (AMLODIPINE BESYLATE) TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110414_b00570ff-4081-4514-b45b-eb6f753450f5.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
amlodipine besylate	AMLODIPINE BESYLATE	Mylan Pharmaceuticals Inc.	180ee374-24f2-4b9c-9d54-8815f2b1dc9b	2024-11-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019787 application number: NDA019787
Norvasc	AMLODIPINE BESYLATE	Viatris Specialty LLC	7367289c-b0b0-466a-83e2-558e2985c29f	2023-02-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019787 application number: NDA019787
amlodipine besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	f3482709-c5c3-4bd0-8067-ad57f31bb525	2022-10-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019787 application number: NDA019787
Norvasc	AMLODIPINE BESYLATE	PFIZER LABORATORIES DIV PFIZER INC	abd6a2ca-40c2-485c-bc53-db1c652505ed	2019-01-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019787 application number: NDA019787

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	b00570ff-4081-4514-b45b-eb6f753450f5	1
212549	Norvasc 5 MG Oral Tablet	PSN	b00570ff-4081-4514-b45b-eb6f753450f5	1
212549	amlodipine 5 MG Oral Tablet [Norvasc]	SBD	b00570ff-4081-4514-b45b-eb6f753450f5	1
197361	amlodipine 5 MG Oral Tablet	SCD	b00570ff-4081-4514-b45b-eb6f753450f5	1
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	b00570ff-4081-4514-b45b-eb6f753450f5	1
212549	Norvasc (as amlodipine besylate) 5 MG Oral Tablet	SY	b00570ff-4081-4514-b45b-eb6f753450f5	1
212549	Norvasc 5 MG Oral Tablet	SY	b00570ff-4081-4514-b45b-eb6f753450f5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-151-15	21695015115	15 in 1 BOTTLE	Historical