Amlodipine Besylate

Product NDC: 69150-115
11-digit product format: 691500115
Labeler code: 69150
Product ID: 69150-115_f85efa7d-67e6-443a-bfca-f0c4a39af8f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine Besylate
Dosage form: TABLET
Route: ORAL
Labeler: BIOMES PHARMACEUTICALS LLC
Application: ANDA077516
Marketing category: ANDA
Marketing start: 2011-04-15
Marketing end: 0000-00-00
Substance: AMLODIPINE BESYLATE
Active strength: 10 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69150-115		I	Inactivated by FDA	2026-09-14
excluded package	package	69150-115	69150-115-01	D	Discontinued by firm	2026-09-14
excluded package	package	69150-115	69150-115-03	I	Inactivated by FDA	2026-09-14
excluded package	package	69150-115	69150-115-05	I	Inactivated by FDA	2026-09-14
excluded package	package	69150-115	69150-115-10	I	Inactivated by FDA	2026-09-14
excluded package	package	69150-115	69150-115-90	I	Inactivated by FDA	2026-09-14

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 2 · 97 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69150-115-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69150-115-03	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69150-115-90	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69150-115-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69150-115-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69150-115-05	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69150-115-03	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69150-115-90	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69150-115-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69150-115-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69150-115-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69150-115-03	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69150-115-90	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69150-115-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69150-115-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69150-115-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69150-115-03	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69150-115-90	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69150-115-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69150-115-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69150-115-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69150-115-03	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69150-115-90	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69150-115-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69150-115-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69150-115-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69150-115-03	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69150-115-90	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69150-115-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69150-115-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69150-115-05	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69150-115-03	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69150-115-90	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69150-115-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69150-115-10	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69150-115-05	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69150-115-03	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69150-115-90	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69150-115-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69150-115-10	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69150-115-05	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69150-115-03	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69150-115-90	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69150-115-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69150-115-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69150-115-05	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69150-115-03	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69150-115-90	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69150-115-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69150-115-10	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A077516-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-11
A077516-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-07-11
A077516-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-07-11

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 · 129 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
2026-09-14 22:38:34	2026-08	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL		2007-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2007-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2007-07-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL		2007-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL		2007-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL		2007-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2007-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077516-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2007-07-11	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 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	A077516-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077516-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077516-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077516-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077516-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077516-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077516-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077516-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077516-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077516-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077516-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077516-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077516-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077516-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077516-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077516-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077516-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077516-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077516-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077516-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077516-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077516-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077516-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077516-001	AB	1	`8072bd15b7f6…`

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, Related label table
NDC	Effective	Related label
69150-115-01	2023-01-30	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYL
69150-115-03	2023-01-30	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYL
69150-115-05	2023-01-30	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYL
69150-115-10	2023-01-30	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYL
69150-115-90	2023-01-30	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYL
69150-115-01	2021-01-15	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYL
69150-115-03	2021-01-15	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYL
69150-115-05	2021-01-15	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYL
69150-115-10	2021-01-15	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYL
69150-115-90	2021-01-15	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYL
69150-115-01	2020-01-31	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYL
69150-115-03	2020-01-31	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYL
69150-115-05	2020-01-31	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYL
69150-115-10	2020-01-31	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYL
69150-115-90	2020-01-31	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69150-115-01	Amlodipine Besylate	100 in 1 BOTTLE	TABLET	100	6
69150-115-03	Amlodipine Besylate	300 in 1 BOTTLE	TABLET	300	6
69150-115-05	Amlodipine Besylate	500 in 1 BOTTLE	TABLET	500	6
69150-115-10	Amlodipine Besylate	1000 in 1 BOTTLE	TABLET	1000	6
69150-115-90	Amlodipine Besylate	90 in 1 BOTTLE	TABLET	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69150-115-01	EA - Each	69150-115	61ae164f-1bfd-4340-8f75-477d0bfbad2c	1	2016-04-04
69150-115-10	EA - Each	69150-115	ae843cde-9b2d-40c0-b744-6c7f2ae42c1c	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69150-115	AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [BIOMES PHARMACEUTICALS LLC]	6	Legacy NDC, 5 package rows	20210116_829aad05-7f21-41c2-b80b-2da793ae70d7.zip

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
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	829aad05-7f21-41c2-b80b-2da793ae70d7	6
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	829aad05-7f21-41c2-b80b-2da793ae70d7	6
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	829aad05-7f21-41c2-b80b-2da793ae70d7	6
308135	amlodipine 10 MG Oral Tablet	SCD	829aad05-7f21-41c2-b80b-2da793ae70d7	6
308136	amlodipine 2.5 MG Oral Tablet	SCD	829aad05-7f21-41c2-b80b-2da793ae70d7	6
197361	amlodipine 5 MG Oral Tablet	SCD	829aad05-7f21-41c2-b80b-2da793ae70d7	6
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	829aad05-7f21-41c2-b80b-2da793ae70d7	6
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	829aad05-7f21-41c2-b80b-2da793ae70d7	6
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	829aad05-7f21-41c2-b80b-2da793ae70d7	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69150-115-01	69150011501	100 in 1 BOTTLE						Historical
69150-115-03	69150011503	300 TABLET in 1 BOTTLE (69150-115-03)	300 tablet	2018-07-25	0000-00-00	No	No	Current
69150-115-05	69150011505	500 TABLET in 1 BOTTLE (69150-115-05)	500 tablet	2018-07-25	0000-00-00	No	No	Current
69150-115-10	69150011510	1000 TABLET in 1 BOTTLE (69150-115-10)	1000 tablet	2018-07-25	0000-00-00	No	No	Current
69150-115-90	69150011590	90 TABLET in 1 BOTTLE (69150-115-90)	90 tablet	2018-07-25	0000-00-00	No	No	Current