FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
29300-398
11-digit product format
293000398
Labeler code
29300
Product ID
29300-398_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
10 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 BESYLATE10 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
29300-398-05Amlodipine Besylate500 in 1 BOTTLE, PLASTICTABLET5004
29300-398-10Amlodipine Besylate1000 in 1 BOTTLE, PLASTICTABLET10004
29300-398-19Amlodipine Besylate90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-398AMLODIPINE 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
308135amLODIPine besylate 10 MG Oral TabletPSNb1151904-5085-49bd-94ec-cb2894f4eb10104
308135amlodipine 10 MG Oral TabletSCDb1151904-5085-49bd-94ec-cb2894f4eb10104
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYb1151904-5085-49bd-94ec-cb2894f4eb10104
308135amLODIPine besylate 10 MG Oral TabletPSNb4cc6d7e-923b-e81c-e053-2995a90a07314
308135amLODIPine besylate 10 MG Oral TabletPSNa516b336-8f60-4b86-8921-c7d6c07629f24
308135amLODIPine besylate 10 MG Oral TabletPSN5a67bbdc-ac1f-4778-bbdc-929df140b7f54
308136amLODIPine besylate 2.5 MG Oral TabletPSNa516b336-8f60-4b86-8921-c7d6c07629f24
197361amLODIPine besylate 5 MG Oral TabletPSNa516b336-8f60-4b86-8921-c7d6c07629f24
308135amlodipine 10 MG Oral TabletSCD5a67bbdc-ac1f-4778-bbdc-929df140b7f54
308135amlodipine 10 MG Oral TabletSCDb4cc6d7e-923b-e81c-e053-2995a90a07314
308135amlodipine 10 MG Oral TabletSCDa516b336-8f60-4b86-8921-c7d6c07629f24
308136amlodipine 2.5 MG Oral TabletSCDa516b336-8f60-4b86-8921-c7d6c07629f24
197361amlodipine 5 MG Oral TabletSCDa516b336-8f60-4b86-8921-c7d6c07629f24
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY5a67bbdc-ac1f-4778-bbdc-929df140b7f54
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYb4cc6d7e-923b-e81c-e053-2995a90a07314
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
308135amLODIPine besylate 10 MG Oral TabletPSNb2d5cccd-e5ff-2909-e053-2a95a90a97733
308135amLODIPine besylate 10 MG Oral TabletPSN0c7d1f99-dfe0-7041-e063-6294a90a97053
308135amLODIPine besylate 10 MG Oral TabletPSN743ae641-14e1-456b-80e6-c6f7d621e9693
308135amlodipine 10 MG Oral TabletSCDb2d5cccd-e5ff-2909-e053-2a95a90a97733
308135amlodipine 10 MG Oral TabletSCD743ae641-14e1-456b-80e6-c6f7d621e9693
308135amlodipine 10 MG Oral TabletSCD0c7d1f99-dfe0-7041-e063-6294a90a97053
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY0c7d1f99-dfe0-7041-e063-6294a90a97053
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYb2d5cccd-e5ff-2909-e053-2a95a90a97733
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY743ae641-14e1-456b-80e6-c6f7d621e9693
308135amLODIPine besylate 10 MG Oral TabletPSN5f3ac64c-6e33-40c1-9b8e-dc0c8dd7e8d62
308135amLODIPine besylate 10 MG Oral TabletPSN0de6a6d0-a114-e114-e063-6394a90a34dd2
308135amlodipine 10 MG Oral TabletSCD5f3ac64c-6e33-40c1-9b8e-dc0c8dd7e8d62
308135amlodipine 10 MG Oral TabletSCD0de6a6d0-a114-e114-e063-6394a90a34dd2
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY5f3ac64c-6e33-40c1-9b8e-dc0c8dd7e8d62
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY0de6a6d0-a114-e114-e063-6394a90a34dd2
308135amLODIPine besylate 10 MG Oral TabletPSN5c50c3fe-afe5-459e-95c0-c9af4cbb69091
308135amLODIPine besylate 10 MG Oral TabletPSN41af64c4-b788-d827-e063-6394a90a91571
308135amLODIPine besylate 10 MG Oral TabletPSN3e0fbf93-cc64-4fa5-b586-c2020614c8841
308135amlodipine 10 MG Oral TabletSCD5c50c3fe-afe5-459e-95c0-c9af4cbb69091
308135amlodipine 10 MG Oral TabletSCD41af64c4-b788-d827-e063-6394a90a91571
308135amlodipine 10 MG Oral TabletSCD3e0fbf93-cc64-4fa5-b586-c2020614c8841
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY5c50c3fe-afe5-459e-95c0-c9af4cbb69091
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY41af64c4-b788-d827-e063-6394a90a91571
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY3e0fbf93-cc64-4fa5-b586-c2020614c8841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-398-0529300039805500 TABLET in 1 BOTTLE, PLASTIC (29300-398-05) 500 tablet2020-06-220000-00-00NoNoCurrent
29300-398-10293000398101000 TABLET in 1 BOTTLE, PLASTIC (29300-398-10) 1000 tablet2020-06-220000-00-00NoNoCurrent
29300-398-192930003981990 TABLET in 1 BOTTLE, PLASTIC (29300-398-19) 90 tablet2020-06-220000-00-00NoNoCurrent