Amlodipine Besylate

Product NDC
31722-238
11-digit product format
317220238
Labeler code
31722
Product ID
31722-238_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
5 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
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
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
31722-238-10EA - Each31722-238664f19b5-6304-492f-8450-5bcecd08e86e12012-07-24
31722-238-90EA - Each31722-238fbe73c7a-64ee-4735-9a6e-ee9c52eedf1b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [BLENHEIM PHARMACAL, INC.]7
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [BLENHEIM PHARMACAL, INC.]7
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [BLENHEIM PHARMACAL, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [BLENHEIM PHARMACAL, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [BLENHEIM PHARMACAL, INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [BLENHEIM PHARMACAL, INC.]7
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [TYA PHARMACEUTICALS]2
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [TYA PHARMACEUTICALS]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [TYA PHARMACEUTICALS]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [TYA PHARMACEUTICALS]2
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [DIRECT RX]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [DIRECT RX]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [DIRECT RX]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [DIRECT RX]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
308135amLODIPine besylate 10 MG Oral TabletPSNeefd43c3-028c-43d6-aa51-26d7157ea8f37
197361amLODIPine besylate 5 MG Oral TabletPSNeefd43c3-028c-43d6-aa51-26d7157ea8f37
308135amlodipine 10 MG Oral TabletSCDeefd43c3-028c-43d6-aa51-26d7157ea8f37
197361amlodipine 5 MG Oral TabletSCDeefd43c3-028c-43d6-aa51-26d7157ea8f37
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYeefd43c3-028c-43d6-aa51-26d7157ea8f37
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYeefd43c3-028c-43d6-aa51-26d7157ea8f37
197361amLODIPine besylate 5 MG Oral TabletPSN2829814d-739d-4ff4-9371-bee70bf322485
197361amlodipine 5 MG Oral TabletSCD2829814d-739d-4ff4-9371-bee70bf322485
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY2829814d-739d-4ff4-9371-bee70bf322485
197361amLODIPine besylate 5 MG Oral TabletPSN551c5efd-9e40-4015-92f8-6fbb229b548e2
197361amlodipine 5 MG Oral TabletSCD551c5efd-9e40-4015-92f8-6fbb229b548e2
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY551c5efd-9e40-4015-92f8-6fbb229b548e2
308135amLODIPine besylate 10 MG Oral TabletPSN51e87d92-0c8a-46fa-a2d6-a8abf555201f1
308135amLODIPine besylate 10 MG Oral TabletPSN5977d47a-fe43-830e-e053-2a91aa0a9f3d1
308136amLODIPine besylate 2.5 MG Oral TabletPSN51e87d92-0c8a-46fa-a2d6-a8abf555201f1
197361amLODIPine besylate 5 MG Oral TabletPSN5977d47a-fe43-830e-e053-2a91aa0a9f3d1
197361amLODIPine besylate 5 MG Oral TabletPSN51e87d92-0c8a-46fa-a2d6-a8abf555201f1
308135amlodipine 10 MG Oral TabletSCD51e87d92-0c8a-46fa-a2d6-a8abf555201f1
308135amlodipine 10 MG Oral TabletSCD5977d47a-fe43-830e-e053-2a91aa0a9f3d1
308136amlodipine 2.5 MG Oral TabletSCD51e87d92-0c8a-46fa-a2d6-a8abf555201f1
197361amlodipine 5 MG Oral TabletSCD5977d47a-fe43-830e-e053-2a91aa0a9f3d1
197361amlodipine 5 MG Oral TabletSCD51e87d92-0c8a-46fa-a2d6-a8abf555201f1
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY5977d47a-fe43-830e-e053-2a91aa0a9f3d1
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 TabletSY5977d47a-fe43-830e-e053-2a91aa0a9f3d1
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY51e87d92-0c8a-46fa-a2d6-a8abf555201f1