atorvastatin calcium

Product NDC
68382-252
11-digit product format
683820252
Labeler code
68382
Product ID
68382-252_5f8a8857-027e-4778-91e6-eb4a7f891652
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA206536
Marketing category
ANDA
Marketing start
2018-11-21
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
80 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-252-10EA - Each68382-252e780ebcb-c50e-4ea8-abec-df6448c6cac512018-12-13
68382-252-16EA - Each68382-252378054c1-81d3-4451-aa08-ac3202eab97f12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-252ATORVASTATIN CALCIUM TABLET [ZYDUS PHARMACEUTICALS USA INC.]11Legacy NDC20241023_f99b0839-28dd-4e77-b920-570af6843052.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSN46eb0d41-4c5a-496c-9084-d0dbd7883b623
259255atorvastatin 80 MG Oral TabletSCD46eb0d41-4c5a-496c-9084-d0dbd7883b623
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY46eb0d41-4c5a-496c-9084-d0dbd7883b623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-252-0168382025201100 TABLET in 1 BOTTLE (68382-252-01) 100 tablet2018-11-210000-00-00NoNoCurrent
68382-252-0568382025205500 TABLET in 1 BOTTLE (68382-252-05) 500 tablet2018-11-210000-00-00NoNoCurrent
68382-252-066838202520630 TABLET in 1 BOTTLE (68382-252-06) 30 tablet2018-11-210000-00-00NoNoCurrent
68382-252-10683820252101000 TABLET in 1 BOTTLE (68382-252-10) 1000 tablet2018-11-210000-00-00NoNoCurrent
68382-252-166838202521690 TABLET in 1 BOTTLE (68382-252-16) 90 tablet2018-11-210000-00-00NoNoCurrent
68382-252-776838202527710 BLISTER PACK in 1 CARTON (68382-252-77) > 10 TABLET in 1 BLISTER PACK (68382-252-30) 10 blister pack2018-11-210000-00-00NoNoCurrent