FDA.reportPublic FDA data

Norvasc

Product NDC
0069-1540
11-digit product format
000691540
Labeler code
0069
Product ID
0069-1540_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
2027-10-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Norvasc

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H
Rxcui197361, 212542, 212549, 212575, 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
0069-1540-41Norvasc1 in 1 BLISTER PACKTABLET129
0069-1540-41Norvasc100 in 1 BOX, UNIT-DOSETABLET10029
0069-1540-68Norvasc90 in 1 BOTTLETABLET9029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-1540-41EA - Each0069-154021d45772-ca9c-493d-82d9-cada0d5d9c2512012-07-24
0069-1540-68EA - Each0069-154072171b72-835e-4617-b0a9-c0c857b9763012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HNORVASC (AMLODIPINE BESYLATE) TABLET [PFIZER LABORATORIES DIV PFIZER INC]11
AMLODIPINEACTIVE MOIETY1J444QC288NORVASC (AMLODIPINE BESYLATE) TABLET [PFIZER LABORATORIES DIV PFIZER INC]11
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JNORVASC (AMLODIPINE BESYLATE) TABLET [PFIZER LABORATORIES DIV PFIZER INC]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNORVASC (AMLODIPINE BESYLATE) TABLET [PFIZER LABORATORIES DIV PFIZER INC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORVASC (AMLODIPINE BESYLATE) TABLET [PFIZER LABORATORIES DIV PFIZER INC]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NORVASC (AMLODIPINE BESYLATE) TABLET [PFIZER LABORATORIES DIV PFIZER INC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-1540NORVASC (AMLODIPINE BESYLATE) TABLET [PFIZER LABORATORIES DIV PFIZER INC]28Current NDC, Legacy NDC, 3 package rows20250125_abd6a2ca-40c2-485c-bc53-db1c652505ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNabd6a2ca-40c2-485c-bc53-db1c652505ed29
308136amLODIPine besylate 2.5 MG Oral TabletPSNabd6a2ca-40c2-485c-bc53-db1c652505ed29
197361amLODIPine besylate 5 MG Oral TabletPSNabd6a2ca-40c2-485c-bc53-db1c652505ed29
212575Norvasc 10 MG Oral TabletPSNabd6a2ca-40c2-485c-bc53-db1c652505ed29
212542Norvasc 2.5 MG Oral TabletPSNabd6a2ca-40c2-485c-bc53-db1c652505ed29
212549Norvasc 5 MG Oral TabletPSNabd6a2ca-40c2-485c-bc53-db1c652505ed29
212575amlodipine 10 MG Oral Tablet [Norvasc]SBDabd6a2ca-40c2-485c-bc53-db1c652505ed29
212542amlodipine 2.5 MG Oral Tablet [Norvasc]SBDabd6a2ca-40c2-485c-bc53-db1c652505ed29
212549amlodipine 5 MG Oral Tablet [Norvasc]SBDabd6a2ca-40c2-485c-bc53-db1c652505ed29
308135amlodipine 10 MG Oral TabletSCDabd6a2ca-40c2-485c-bc53-db1c652505ed29
308136amlodipine 2.5 MG Oral TabletSCDabd6a2ca-40c2-485c-bc53-db1c652505ed29
197361amlodipine 5 MG Oral TabletSCDabd6a2ca-40c2-485c-bc53-db1c652505ed29
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYabd6a2ca-40c2-485c-bc53-db1c652505ed29
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYabd6a2ca-40c2-485c-bc53-db1c652505ed29
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYabd6a2ca-40c2-485c-bc53-db1c652505ed29
212575Norvasc (as amlodipine besylate) 10 MG Oral TabletSYabd6a2ca-40c2-485c-bc53-db1c652505ed29
212542Norvasc (as amlodipine besylate) 2.5 MG Oral TabletSYabd6a2ca-40c2-485c-bc53-db1c652505ed29
212549Norvasc (as amlodipine besylate) 5 MG Oral TabletSYabd6a2ca-40c2-485c-bc53-db1c652505ed29
212575Norvasc 10 MG Oral TabletSYabd6a2ca-40c2-485c-bc53-db1c652505ed29
212542Norvasc 2.5 MG Oral TabletSYabd6a2ca-40c2-485c-bc53-db1c652505ed29
212549Norvasc 5 MG Oral TabletSYabd6a2ca-40c2-485c-bc53-db1c652505ed29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-1540-4100069154041100 BLISTER PACK in 1 BOX, UNIT-DOSE (0069-1540-41) > 1 TABLET in 1 BLISTER PACK100 blister pack1992-07-310000-00-00NoNoCurrent
0069-1540-680006915406890 TABLET in 1 BOTTLE (0069-1540-68) 90 tablet1992-07-312027-10-31NoNoCurrent