FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
29300-397
11-digit product format
293000397
Labeler code
29300
Product ID
29300-397_0f1b84e6-292c-4f46-b475-26c4dec1fbc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA203245
Marketing category
ANDA
Marketing start
2019-05-22
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amlodipine Besylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H
Rxcui197361, 308135, 308136

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29300-397-05Amlodipine Besylate500 in 1 BOTTLE, PLASTICTABLET5004
29300-397-10Amlodipine Besylate1000 in 1 BOTTLE, PLASTICTABLET10004
29300-397-19Amlodipine Besylate90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-397AMLODIPINE BESYLATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]4Current NDC, Legacy NDC, 3 package rows20221206_a516b336-8f60-4b86-8921-c7d6c07629f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197361amLODIPine besylate 5 MG Oral TabletPSN52daa759-3327-461a-8cfc-3c6253df91ec100
197361amlodipine 5 MG Oral TabletSCD52daa759-3327-461a-8cfc-3c6253df91ec100
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY52daa759-3327-461a-8cfc-3c6253df91ec100
197361amLODIPine besylate 5 MG Oral TabletPSN988e5acb-356e-4116-b6db-ab8468ed72348
197361amlodipine 5 MG Oral TabletSCD988e5acb-356e-4116-b6db-ab8468ed72348
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY988e5acb-356e-4116-b6db-ab8468ed72348
308135amLODIPine besylate 10 MG Oral TabletPSNa516b336-8f60-4b86-8921-c7d6c07629f24
308136amLODIPine besylate 2.5 MG Oral TabletPSNa516b336-8f60-4b86-8921-c7d6c07629f24
197361amLODIPine besylate 5 MG Oral TabletPSNa75e4797-6b7f-4366-9105-79d6877adac54
197361amLODIPine besylate 5 MG Oral TabletPSNa516b336-8f60-4b86-8921-c7d6c07629f24
308135amlodipine 10 MG Oral TabletSCDa516b336-8f60-4b86-8921-c7d6c07629f24
308136amlodipine 2.5 MG Oral TabletSCDa516b336-8f60-4b86-8921-c7d6c07629f24
197361amlodipine 5 MG Oral TabletSCDa75e4797-6b7f-4366-9105-79d6877adac54
197361amlodipine 5 MG Oral TabletSCDa516b336-8f60-4b86-8921-c7d6c07629f24
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYa516b336-8f60-4b86-8921-c7d6c07629f24
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYa516b336-8f60-4b86-8921-c7d6c07629f24
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYa516b336-8f60-4b86-8921-c7d6c07629f24
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYa75e4797-6b7f-4366-9105-79d6877adac54
197361amLODIPine besylate 5 MG Oral TabletPSN699d3ba2-a342-4e3d-b8ad-c14e0df64dfe3
197361amLODIPine besylate 5 MG Oral TabletPSNda4e36d3-1ddc-4350-9a00-86975e523f753
197361amLODIPine besylate 5 MG Oral TabletPSNb620e707-7c48-593e-e053-2a95a90a69503
197361amlodipine 5 MG Oral TabletSCDb620e707-7c48-593e-e053-2a95a90a69503
197361amlodipine 5 MG Oral TabletSCD699d3ba2-a342-4e3d-b8ad-c14e0df64dfe3
197361amlodipine 5 MG Oral TabletSCDda4e36d3-1ddc-4350-9a00-86975e523f753
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY699d3ba2-a342-4e3d-b8ad-c14e0df64dfe3
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYda4e36d3-1ddc-4350-9a00-86975e523f753
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYb620e707-7c48-593e-e053-2a95a90a69503
197361amLODIPine besylate 5 MG Oral TabletPSNfc61eee9-ee15-9078-e053-6394a90a22f42
197361amLODIPine besylate 5 MG Oral TabletPSN094498f2-11d9-2a05-e063-6294a90ab2e12
197361amlodipine 5 MG Oral TabletSCDfc61eee9-ee15-9078-e053-6394a90a22f42
197361amlodipine 5 MG Oral TabletSCD094498f2-11d9-2a05-e063-6294a90ab2e12
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYfc61eee9-ee15-9078-e053-6394a90a22f42
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY094498f2-11d9-2a05-e063-6294a90ab2e12
197361amLODIPine besylate 5 MG Oral TabletPSNafcffa7b-03b7-499a-b50c-37b0e28c77371
197361amLODIPine besylate 5 MG Oral TabletPSNc2c51ec3-ffb0-4240-b048-a8e424775a761
197361amLODIPine besylate 5 MG Oral TabletPSN264077bf-28c3-14d6-e063-6394a90ae1f21
197361amlodipine 5 MG Oral TabletSCDafcffa7b-03b7-499a-b50c-37b0e28c77371
197361amlodipine 5 MG Oral TabletSCDc2c51ec3-ffb0-4240-b048-a8e424775a761
197361amlodipine 5 MG Oral TabletSCD264077bf-28c3-14d6-e063-6394a90ae1f21
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYafcffa7b-03b7-499a-b50c-37b0e28c77371
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYc2c51ec3-ffb0-4240-b048-a8e424775a761
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY264077bf-28c3-14d6-e063-6394a90ae1f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-397-0529300039705500 TABLET in 1 BOTTLE, PLASTIC (29300-397-05) 500 tablet2020-06-220000-00-00NoNoCurrent
29300-397-10293000397101000 TABLET in 1 BOTTLE, PLASTIC (29300-397-10) 1000 tablet2020-06-220000-00-00NoNoCurrent
29300-397-192930003971990 TABLET in 1 BOTTLE, PLASTIC (29300-397-19) 90 tablet2020-06-220000-00-00NoNoCurrent