Ergocalciferol Oral Capsule

Brand(s)
Drisdol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2012-06-15)
Oldest Current Product
1974-11-11
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\ERGOCALCIFEROL
FDAOB
ORAL\CAPSULE\ERGOCALCIFEROL
SPL Active
ORAL\CAPSULE, LIQUID FILLED\ERGOCALCIFEROL
ORAL\CAPSULE\ERGOCALCIFEROL
SPL Moiety
ORAL\CAPSULE, LIQUID FILLED\ERGOCALCIFEROL
ORAL\CAPSULE\ERGOCALCIFEROL

product(s) by strength(s)

ergocalciferol 50000 unt oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000240393DrisdolNDASanofi-Aventis U.S. Llc1974-11-11ERGOCALCIFEROLORALCAPSULE, LIQUID FILLEDNDA0034440d501431-82d3-4f8e-94c4-5eabcefc00ad

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1005740194ANDAPaddock Laboratories, Llc2009-12-152015-11-30ERGOCALCIFEROLORALCAPSULE, LIQUID FILLEDANDA09045577090cd4-7064-44d3-9616-173a123ff7fd
2009550251NDA AUTHORIZED GENERICWinthrop U.S.2009-11-10ERGOCALCIFEROLORALCAPSULE, LIQUID FILLEDNDA0034445ce71761-aebc-481b-b31b-05201c8a9d23
3427940006ANDASigmapharm Laboratories, Llc2012-01-28ERGOCALCIFEROLORALCAPSULE, LIQUID FILLEDANDA0910047c040a9d-c19f-4ca2-a095-4f8b60e03a76
4501110990ANDAPliva Inc.2002-06-01ERGOCALCIFEROLORALCAPSULEANDA080704e80cf664-0e4b-433e-b298-dbd2a352f1cf
5519910604ANDABreckenridge Pharmaceutical, Inc.2009-08-17ERGOCALCIFEROLORALCAPSULEANDA040833f1b24841-75a3-4eb8-8854-17ce832ff09d
6576640136ANDACaraco Pharmaceutical Laboratories, Ltd.2010-03-15ERGOCALCIFEROLORALCAPSULEANDA040865154285ad-b575-43a9-b5ba-72c1c8839c1f
7643800737ANDAStrides Arcolab Limited2014-05-16ERGOCALCIFEROLORALCAPSULEANDA0904552c4c0a36-12cf-444d-9d57-de983eef4d36
8649800157ANDARising Pharmaceuticals, Inc.2010-07-23ERGOCALCIFEROLORALCAPSULE, LIQUID FILLEDANDA0910049f9e4491-9c18-487c-8a88-9738dfbad16e
9693870106ANDABanner Life Sciences Llc.2015-06-01ERGOCALCIFEROLORALCAPSULE, LIQUID FILLEDANDA08070453b1ee91-c4e0-450a-8bd1-1220da0daedf

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440527ANDABlenheim Pharmacal, Inc.2013-10-02ERGOCALCIFEROLORALCAPSULE519910604ANDA0408330fefb3a2-f0c6-0544-e054-00144ff8d46c
2332610730ANDAAidarex Pharmaceuticals Llc2009-08-17ERGOCALCIFEROLORALCAPSULE519910604ANDA0408335ed8aad8-99ce-41e7-8c3d-26ecaf5599fd
3353560794ANDALake Erie Medical Dba Quality Care Products Llc2009-08-17ERGOCALCIFEROLORALCAPSULE519910604ANDA040833e0a6689b-1784-4f63-9213-504eea974b42
4422910266ANDAAvkare, Inc.2015-07-23ERGOCALCIFEROLORALCAPSULE, LIQUID FILLED693870106ANDA080704f55eafcd-dfd9-fdae-c39f-ae07aa852ce1
5422910274ANDAAvkare, Inc.2012-06-05ERGOCALCIFEROLORALCAPSULE, LIQUID FILLED649800157ANDA091004a684789b-3174-2585-1056-a9152a97675d
6430630290ANDAPd-Rx Pharmaceuticals, Inc.2009-08-17ERGOCALCIFEROLORALCAPSULE519910604ANDA0408332463cb1e-1381-4ad2-9230-c0bc39e8acee
7430630391ANDAPd-Rx Pharmaceuticals, Inc.2010-03-15ERGOCALCIFEROLORALCAPSULE576640136ANDA0408654c51e005-0dd2-4cec-803c-6d6b315baeda
8433530828ANDAAphena Pharma Solutions - Tennessee, Llc2010-03-15ERGOCALCIFEROLORALCAPSULE576640136ANDA04086515f453ac-84b6-455e-9926-f51b8b9ac0dd
9504363622ANDAUnit Dose Services2010-07-23ERGOCALCIFEROLORALCAPSULE, LIQUID FILLED649800157ANDA0910042f1d9e73-74f1-40e2-87cc-2e29545d2232
10545693176ANDAA-S Medication Solutions Llc2010-03-15ERGOCALCIFEROLORALCAPSULE576640136ANDA040865828d11d6-a2c5-4894-b1a0-1692607b0543
11548685799ANDAPhysicians Total Care, Inc.2007-07-12ERGOCALCIFEROLORALCAPSULE51991060401ANDA04083388218156-081a-4809-8143-f97bdab194ba
12581180157ANDAClinical Solutions Wholesale2010-07-23ERGOCALCIFEROLORALCAPSULE, LIQUID FILLED649800157ANDA091004bccc7cdc-070b-4bb3-a0b2-eaffaf958559
13604290245ANDAGolden State Medical Supply, Inc.2009-08-17ERGOCALCIFEROLORALCAPSULE519910604ANDA04083300c063ce-5a2c-4ccb-87df-6ec3df0c9fa6
14607600749ANDASt Marys Medical Park Pharmacy2014-05-22ERGOCALCIFEROLORALCAPSULE519910604ANDA0408330387677c-fdef-4786-894d-8fbd9b6ef604
15631870064ANDAProficient Rx Lp2010-07-23ERGOCALCIFEROLORALCAPSULE, LIQUID FILLED649800157ANDA09100415aa57c4-c881-485a-9318-9fdaaff2e12e
16631870519ANDAProficient Rx Lp2014-05-16ERGOCALCIFEROLORALCAPSULE643800737ANDA090455548365c1-b51c-4a8b-ae3d-50b41aba12db
17636293748ANDABryant Ranch Prepack2009-08-17ERGOCALCIFEROLORALCAPSULE519910604ANDA040833b0e4452c-95a7-f70a-d9be-59e708dc7822
18642050157ANDAReadymeds2010-07-23ERGOCALCIFEROLORALCAPSULE, LIQUID FILLED649800157ANDA091004a8bab53a-2c6a-403a-b9a8-564fa3592c71
19663360907ANDADispensing Solutions, Inc.2009-08-17ERGOCALCIFEROLORALCAPSULE519910604ANDA0408330525e04f-91b7-4d75-8ff9-a6fb5705d993
20680840463ANDAAmerican Health Packaging2011-01-07ERGOCALCIFEROLORALCAPSULE519910604ANDA040833820ad6a8-a5c7-4e3b-a6d0-bbf6c04bab56
21681510490ANDACarilion Materials Management2010-07-23ERGOCALCIFEROLORALCAPSULE, LIQUID FILLED649800157ANDA09100423ab37c7-27fb-4006-b8c2-4f7741f761a9
22687889256ANDAPreferred Pharmaceuticals, Inc.2015-02-23ERGOCALCIFEROLORALCAPSULE576640136ANDA0408653d741db6-e6cc-4df6-a21d-4d0dcf768122

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040833ERGOCALCIFEROLORIT LABORATORIES LLC2009-05-20ANDA040833_001
2ANDA040865ERGOCALCIFEROLSUN PHARMACEUTICAL INDUSTRIES INC2009-12-29ANDA040865_001
3ANDA080704VITAMIN DBANNER LIFE SCIENCES LLCANDA080704_001
4ANDA080747VITAMIN DTrueCHASE CHEMICAL CO LPANDA080747_001
5ANDA080825VITAMIN DTrueLANNETT CO INCANDA080825_001
6ANDA080884DELTALINTrueELI LILLY AND COANDA080884_001
7ANDA080951VITAMIN DTrueIMPAX LABORATORIES INCANDA080951_001
8ANDA080956VITAMIN DTrueEVERYLIFEANDA080956_001
9ANDA083102VITAMIN DTrueWEST WARD PHARMACEUTICAL CORPANDA083102_001
10ANDA084053VITAMIN DTrueVITARINE PHARMACEUTICALS INCANDA084053_001
11ANDA090455ERGOCALCIFEROLSTRIDES PHARMA GLOBAL PTE LTD2010-08-03ANDA090455_001
12ANDA091004ERGOCALCIFEROLSIGMAPHARM LABORATORIES LLC2010-07-14ANDA091004_001
13NDA003444DRISDOLSANOFI AVENTIS US LLCNDA003444_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040833_001RXERGOCALCIFEROL (50,000 IU)ORALCAPSULEFalseAA2009-05-20ERGOCALCIFEROL
2ANDA040865_001RXERGOCALCIFEROL (50,000 IU)ORALCAPSULEFalseAA2009-12-29ERGOCALCIFEROL
3ANDA080704_001RXERGOCALCIFEROL (50,000 IU)ORALCAPSULEFalseAAVITAMIN D
4ANDA080747_001discontinuedERGOCALCIFEROL (50,000 IU)ORALCAPSULEFalseVITAMIN D
5ANDA080825_001discontinuedERGOCALCIFEROL (50,000 IU)ORALCAPSULEFalseVITAMIN D
6ANDA080884_001discontinuedERGOCALCIFEROL (50,000 IU)ORALCAPSULEFalseDELTALIN
7ANDA080951_001discontinuedERGOCALCIFEROL (50,000 IU)ORALCAPSULEFalseVITAMIN D
8ANDA080956_001discontinuedERGOCALCIFEROL (50,000 IU)ORALCAPSULEFalseVITAMIN D
9ANDA083102_001discontinuedERGOCALCIFEROL (50,000 IU)ORALCAPSULEFalseVITAMIN D
10ANDA084053_001discontinuedERGOCALCIFEROL (50,000 IU)ORALCAPSULEFalseVITAMIN D
11ANDA090455_001RXERGOCALCIFEROL (50,000 IU)ORALCAPSULEFalseAA2010-08-03ERGOCALCIFEROL
12ANDA091004_001RXERGOCALCIFEROL (50,000 IU)ORALCAPSULEFalseAA2010-07-14ERGOCALCIFEROL
13NDA003444_001RXERGOCALCIFEROL (50,000 IU)ORALCAPSULETrueAADRISDOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
100c063ce-5a2c-4ccb-87df-6ec3df0c9fa6 (view SPL)VITAMIN D, ERGOCALCIFEROL Capsules, USP, 1.25 mg SOFTGEL CAPSULES (Soft Gelatin Capsules) (50,000 USP Units)prescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2012-01-093604290245
20387677c-fdef-4786-894d-8fbd9b6ef604 (view SPL)VITAMIN D,ERGOCALCIFEROLCapsules, USP,1.25 mg SOFTGEL CAPSULES(Soft Gelatin Capsules)(50,000 USP Units)prescriptionHuman PrescriptionSt Marys Medical Park Pharmacymanufacture, relabel, repack2015-01-143607600749
30525e04f-91b7-4d75-8ff9-a6fb5705d993 (view SPL)prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2012-02-061663360907
40d501431-82d3-4f8e-94c4-5eabcefc00ad (view SPL)DRISDOL ERGOCALCIFEROL, USP 50,000 IU CapsuleprescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2012-06-155000240393
50fefb3a2-f0c6-0544-e054-00144ff8d46c (view SPL)VITAMIN D, ERGOCALCIFEROL Capsules, USP, 1.25 mg SOFTGEL CAPSULES (Soft Gelatin Capsules) (50,000 USP Units)prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-02-251105440527
6154285ad-b575-43a9-b5ba-72c1c8839c1f (view SPL)prescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.MANUFACTURE2015-02-126576640136
715aa57c4-c881-485a-9318-9fdaaff2e12e (view SPL)VITAMIN D (Ergocalciferol Capsules, USP) 1.25 mg (50,000 USP Units)prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-04-301631870064
815f453ac-84b6-455e-9926-f51b8b9ac0dd (view SPL)prescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2013-07-191433530828
923ab37c7-27fb-4006-b8c2-4f7741f761a9 (view SPL)VITAMIN D (Ergocalciferol Capsules, USP) 1.25 mg (50,000 USP Units)prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2010-12-122681510490
102463cb1e-1381-4ad2-9230-c0bc39e8acee (view SPL)VITAMIN D,ERGOCALCIFEROLCapsules, USP,1.25 mg SOFTGEL CAPSULES(Soft Gelatin Capsules)(50,000 USP Units)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-07-141430630290
112c4c0a36-12cf-444d-9d57-de983eef4d36 (view SPL)VITAMIN D (Ergocalciferol Capsules, USP)1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.prescriptionHuman PrescriptionStrides Arcolab LimitedAnalysis, Manufacture, Pack2014-08-262643800737
122f1d9e73-74f1-40e2-87cc-2e29545d2232 (view SPL)VITAMIN D (Ergocalciferol Capsules, USP) 1.25 mg (50,000 USP Units)prescriptionHuman PrescriptionUnit Dose ServicesREPACK2010-12-122504363622
133d741db6-e6cc-4df6-a21d-4d0dcf768122 (view SPL)prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-02-231687889256
144c51e005-0dd2-4cec-803c-6d6b315baeda (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-01-054430630391
1553b1ee91-c4e0-450a-8bd1-1220da0daedf (view SPL)Ergocalciferol Capsules, USPprescriptionHuman PrescriptionBanner Life Sciences Llc.MANUFACTURE2015-06-111693870106
16548365c1-b51c-4a8b-ae3d-50b41aba12db (view SPL)VITAMIN D (Ergocalciferol Capsules, USP)1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870519
175ce71761-aebc-481b-b31b-05201c8a9d23 (view SPL)ERGOCALCIFEROL, USP 50,000 IU CapsuleprescriptionHuman PrescriptionWinthrop U.S.ANALYSIS, LABEL, MANUFACTURE, PACK2012-06-184009550251
185ed8aad8-99ce-41e7-8c3d-26ecaf5599fd (view SPL)VITAMIN D,ERGOCALCIFEROLCapsules, USP,1.25 mg SOFTGEL CAPSULES(Soft Gelatin Capsules)(50,000 USP Units)prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-02-021332610730
1977090cd4-7064-44d3-9616-173a123ff7fd (view SPL)Vitamin D (Ergocalciferol Capsules, USP) 1.25 MG (50,000 USP Units)prescriptionHuman PrescriptionPaddock Laboratories, Llc2015-04-216005740194
207c040a9d-c19f-4ca2-a095-4f8b60e03a76 (view SPL)VITAMIN D (Ergocalciferol Capsules, USP) 1.25 mg (50,000 USP Units)prescriptionHuman PrescriptionSigmapharm Laboratories, Llcanalysis, manufacture2012-01-253427940006
21820ad6a8-a5c7-4e3b-a6d0-bbf6c04bab56 (view SPL)VITAMIN D (Ergocalciferol Capsules, USP)prescriptionHuman PrescriptionAmerican Health Packagingrepack2015-10-262680840463
22828d11d6-a2c5-4894-b1a0-1692607b0543 (view SPL)prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-10-261545693176
2388218156-081a-4809-8143-f97bdab194ba (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-10-112548685799
249f9e4491-9c18-487c-8a88-9738dfbad16e (view SPL)VITAMIN D (Ergocalciferol Capsules, USP) 1.25 mg (50,000 USP Units)prescriptionHuman PrescriptionRising Pharmaceuticals, Inc.2010-12-122649800157
25a684789b-3174-2585-1056-a9152a97675d (view SPL)VITAMIN D (Ergocalciferol Capsules, USP) 1.25 mg (50,000 USP Units)prescriptionHuman PrescriptionAvkare, Inc.2013-08-236422910274
26a8bab53a-2c6a-403a-b9a8-564fa3592c71 (view SPL)VITAMIN D (Ergocalciferol Capsules, USP) 1.25 mg (50,000 USP Units)prescriptionHuman PrescriptionReadymedsrepack2014-07-013642050157
27b0e4452c-95a7-f70a-d9be-59e708dc7822 (view SPL)VITAMIN D,prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-171002636293748
28bccc7cdc-070b-4bb3-a0b2-eaffaf958559 (view SPL)VITAMIN D (Ergocalciferol Capsules, USP) 1.25 mg (50,000 USP Units)prescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2013-08-114581180157
29e0a6689b-1784-4f63-9213-504eea974b42 (view SPL)VITAMIN D,ERGOCALCIFEROLCapsules, USP,1.25 mg SOFTGEL CAPSULES(Soft Gelatin Capsules)(50,000 USP Units)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-06-121353560794
30e80cf664-0e4b-433e-b298-dbd2a352f1cf (view SPL)Ergocalciferol Capsules, USP Rx OnlyprescriptionHuman PrescriptionPliva Inc.ANALYSIS, MANUFACTURE2013-03-207501110990
31f1b24841-75a3-4eb8-8854-17ce832ff09d (view SPL)VITAMIN D,ERGOCALCIFEROLCapsules, USP,1.25 mg SOFTGEL CAPSULES(Soft Gelatin Capsules)(50,000 USP Units)prescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.2009-07-141519910604
32f55eafcd-dfd9-fdae-c39f-ae07aa852ce1 (view SPL)Ergocalciferol Capsules, USPprescriptionHuman PrescriptionAvkare, Inc.2015-07-312422910266

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII