Amlodipine Besylate

Product NDC
31722-237
11-digit product format
317220237
Labeler code
31722
Product ID
31722-237_0cb6772a-957b-4193-bdaa-270ae69f6c1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA077955
Marketing category
ANDA
Marketing start
2011-01-01
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
3 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

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-237-10EA - Each31722-23788bfb26d-b8ca-4fc0-a044-0b273735d5b712012-07-24
31722-237-90EA - Each31722-23749f9bafe-43ba-462b-b865-5a814e940d2712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HHYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
ARGININEACTIVE INGREDIENT94ZLA3W45FHYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
AMLODIPINEACTIVE MOIETY1J444QC288HYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
ARGININEACTIVE MOIETY94ZLA3W45FHYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JHYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
GELATININACTIVE INGREDIENT2G86QN327LHYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DHYPERTENIPINE (AMLODIPINE BESYLATE, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308136amLODIPine besylate 2.5 MG Oral TabletPSN2fcc87a4-74ef-46bd-8ee9-bd2f3cf3d0c27
308136amlodipine 2.5 MG Oral TabletSCD2fcc87a4-74ef-46bd-8ee9-bd2f3cf3d0c27
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY2fcc87a4-74ef-46bd-8ee9-bd2f3cf3d0c27
308135amLODIPine besylate 10 MG Oral TabletPSN51e87d92-0c8a-46fa-a2d6-a8abf555201f1
308136amLODIPine besylate 2.5 MG Oral TabletPSN51e87d92-0c8a-46fa-a2d6-a8abf555201f1
197361amLODIPine besylate 5 MG Oral TabletPSN51e87d92-0c8a-46fa-a2d6-a8abf555201f1
308135amlodipine 10 MG Oral TabletSCD51e87d92-0c8a-46fa-a2d6-a8abf555201f1
308136amlodipine 2.5 MG Oral TabletSCD51e87d92-0c8a-46fa-a2d6-a8abf555201f1
197361amlodipine 5 MG Oral TabletSCD51e87d92-0c8a-46fa-a2d6-a8abf555201f1
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY51e87d92-0c8a-46fa-a2d6-a8abf555201f1
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY51e87d92-0c8a-46fa-a2d6-a8abf555201f1
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY51e87d92-0c8a-46fa-a2d6-a8abf555201f1