Norvasc

Product NDC: 0069-1530
Requested package NDC: 0069-1530-41
11-digit product format: 000691530
Labeler code: 0069
Product ID: 0069-1530_3714a872-b6c6-4d74-88d2-add8a895e311
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine besylate
Dosage form: TABLET
Route: ORAL
Labeler: PFIZER LABORATORIES DIV PFIZER INC
Application: NDA019787
Marketing category: NDA
Marketing start: 1992-07-31
Marketing end: 2027-07-31
Substance: AMLODIPINE BESYLATE
Active strength: 5 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag: No
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0069-1530	0069-1530-41	D	Discontinued by firm		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 1 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0069-1530	0069-1530-41	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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	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 · 129 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
2026-09-14 22:38:34	2026-08	N019787-001	NORVASC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019787-002	NORVASC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1992-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019787-003	NORVASC	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	1992-07-31	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N019787-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019787-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019787-003	AB	1	`84e616aacf4f…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Norvasc

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMLODIPINE BESYLATE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
864V2Q084H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197361	Internal RxNorm lookup
212542	Internal RxNorm lookup
212549	Internal RxNorm lookup
212575	Internal RxNorm lookup
308135	Internal RxNorm lookup
308136	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
abd6a2ca-40c2-485c-bc53-db1c652505ed	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	SPL version
0069-1530-41	Norvasc	100 in 1 BOX, UNIT-DOSE	TABLET	100	29
0069-1530-41	Norvasc	1 in 1 BLISTER PACK	TABLET	1	29
0069-1530-68	Norvasc	90 in 1 BOTTLE	TABLET	90	29
0069-1530-72	Norvasc	300 in 1 BOTTLE	TABLET	300	29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0069-1530-41	EA - Each	0069-1530	182453c3-87dd-47a4-aa53-7c54995d74fb	1	2012-07-24
0069-1530-68	EA - Each	0069-1530	3bafdaac-fccd-4fdb-904e-5c1b7a5d3fce	1	2012-07-24
0069-1530-72	EA - Each	0069-1530	8801fad1-126b-49e9-9b30-ed21a3ece578	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 [PFIZER LABORATORIES DIV PFIZER INC]	11
AMLODIPINE	ACTIVE MOIETY	1J444QC288	NORVASC (AMLODIPINE BESYLATE) TABLET [PFIZER LABORATORIES DIV PFIZER INC]	11
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	NORVASC (AMLODIPINE BESYLATE) TABLET [PFIZER LABORATORIES DIV PFIZER INC]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NORVASC (AMLODIPINE BESYLATE) TABLET [PFIZER LABORATORIES DIV PFIZER INC]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NORVASC (AMLODIPINE BESYLATE) TABLET [PFIZER LABORATORIES DIV PFIZER INC]	11
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NORVASC (AMLODIPINE BESYLATE) TABLET [PFIZER LABORATORIES DIV PFIZER INC]	11
amlodipine besylate	ACTIVE INGREDIENT	864V2Q084H	NORVASC (AMLODIPINE BESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.]	8
Amlodipine	ACTIVE MOIETY	1J444QC288	NORVASC (AMLODIPINE BESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.]	8
anhydrous dibasic calcium phosphate	INACTIVE INGREDIENT	L11K75P92J	NORVASC (AMLODIPINE BESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.]	8
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	NORVASC (AMLODIPINE BESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.]	8
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	NORVASC (AMLODIPINE BESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.]	8
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	NORVASC (AMLODIPINE BESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.]	8
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
0069-1530	NORVASC (AMLODIPINE BESYLATE) TABLET [PFIZER LABORATORIES DIV PFIZER INC]	28	Current NDC, Legacy NDC, 4 package rows	20250125_abd6a2ca-40c2-485c-bc53-db1c652505ed.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 ndc (package): 0069-1530-41 ndc (product): 0069-1530 ndc11 (package): 00069153041

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	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
212575	Norvasc 10 MG Oral Tablet	PSN	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
212542	Norvasc 2.5 MG Oral Tablet	PSN	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
212549	Norvasc 5 MG Oral Tablet	PSN	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
212575	amlodipine 10 MG Oral Tablet [Norvasc]	SBD	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
212542	amlodipine 2.5 MG Oral Tablet [Norvasc]	SBD	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
212549	amlodipine 5 MG Oral Tablet [Norvasc]	SBD	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
308135	amlodipine 10 MG Oral Tablet	SCD	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
308136	amlodipine 2.5 MG Oral Tablet	SCD	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
197361	amlodipine 5 MG Oral Tablet	SCD	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
212575	Norvasc (as amlodipine besylate) 10 MG Oral Tablet	SY	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
212542	Norvasc (as amlodipine besylate) 2.5 MG Oral Tablet	SY	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
212549	Norvasc (as amlodipine besylate) 5 MG Oral Tablet	SY	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
212575	Norvasc 10 MG Oral Tablet	SY	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
212542	Norvasc 2.5 MG Oral Tablet	SY	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
212549	Norvasc 5 MG Oral Tablet	SY	abd6a2ca-40c2-485c-bc53-db1c652505ed	29
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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0069-1530-41	00069153041	100 BLISTER PACK in 1 BOX, UNIT-DOSE (0069-1530-41) > 1 TABLET in 1 BLISTER PACK	100 blister pack	1992-07-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Norvasc	PD-Rx Pharmaceuticals, Inc.	2022-04-18	HUMAN PRESCRIPTION DRUG LABEL	20
Norvasc	PFIZER LABORATORIES DIV PFIZER INC	2019-01-15	HUMAN PRESCRIPTION DRUG LABEL	29
Norvasc	Rebel Distributors Corp	2010-12-28	HUMAN PRESCRIPTION DRUG LABEL	1