FDA.reportPublic FDA data

SHELLAC

Substance profile for UNII 46N107B71O, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Substance Identity#

UNII
46N107B71O
Preferred term
SHELLAC
Registry number
9000-59-3
EC number
232-549-9
Ingredient type
INGREDIENT SUBSTANCE

Chemical And Database Identifiers#

RxCUI
1368898
PubChem
0
NCIt
C66001
INN ID
0
NCBI
473130

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
RxNorm1368898mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1368898
NCI ThesaurusC66001ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C66001
FDA Substance Registration System46N107B71Oprecision.fda.gov/uniisearch/srs/unii/46N107B71O
European Community number232-549-9commonchemistry.cas.org/results?q=232-549-9

Legacy UNII Aliases#

Legacy UNII, Term, Last update table
Legacy UNIITermLast update
46N107B71OSHELLAC2019-03-18 19:36:14

DailyMed Socrata Ingredients#

DailyMed label, SPL version table
DailyMed labelSPL version
These highlights do not include all the information needed to use tamsulosin hydrochloride capsules safely and effectively. See full prescribing information for tamsulosin hydrochloride capsules. TAMSULOSIN hydrochloride capsules USP, 0.4 mg for oral use Initial U.S. Approval: 19976
LANSOPRAZOLE7
PANTOPRAZOLE SODIUM5
Terazosin Capsules, USP10
Terazosin Hydrochloride Capsules9
Chlorpromazine Hydrochloride Tablets, USP5
These highlights do not include all the information needed to use esomeprazole magnesium safely and effectively. See full prescribing information for esomeprazole magnesium. Esomeprazole magnesium delayed-release capsules USP, for oral use Initial U.S. Approval: 1989 (omeprazole)6
These highlights do not include all the information needed to use duloxetine delayed-release capsules, USP safely and effectively. See full prescribing information for duloxetine delayed-release capsules, USP. DULOXETINE delayed-release capsules USP, for oral use. Initial U.S. Approval: 20047
Indomethacin Capsules USP, 25 mg and 50 mg5
These highlights do not include all the information needed to use tacrolimus capsules safely and effectively. See full prescribing information for tacrolimus capsules. TACROLIMUS Capsules, USP for oral use Initial U.S. Approval: 19946
BENZONATATE CAPSULES, USP Rx Only5
Indomethacin Extended – Release Capsules, USP 75 mg5
c635af0d-b005-4bce-8c43-24d0508c28ad5
These highlights do not include all the information needed to use omeprazole delayed-release capsules safely and effectively. See full prescribing information for omeprazole delayed-release capsules. OMEPRAZOLE Delayed-Release Capsules USP Initial U.S. Approval: 19895
These highlights do not include all the information needed to use PANTOPRAZOLE sodium delayed-release tablets, USP safely and effectively. See full prescribing information for PANTOPRAZOLE sodium delayed-release tablets, USP. PANTOPRAZOLE sodium delayed-release tablets, USP, for oral administration Initial U.S. approval: 200011
GABAPENTIN CAPSULES, USP5
These highlights do not include all the information needed to use OMEPRAZOLE delayed-release capsules, USP safely and effectively. See full prescribing information for OMEPRAZOLE delayed-release capsules, USP . OMEPRAZOLE Delayed-Release Capsules, USP , for oral use INITIAL U.S. APPROVAL: 198915
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES USP 7384 7385 7386 Rx only7
These highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE Capsules, USP for Oral Use Initial U.S. Approval: 19874
NITROFURANTOIN CAPSULES USP (Macrocrystals) Rx only 2130 21311002
DRUG FACTS1001
These highlights do not include all the information needed to use pantoprazole sodium delayed-release tablets USP safely and effectively. See full prescribing information for pantoprazole sodium delayed-release tablets USP. PANTOPRAZOLE sodium delayed-release tablets USP for oral use Initial U.S. Approval: 20001001
These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. AMLODIPINE besylate and BENAZEPRIL hydrochloride capsules for oral use Initial U.S. Approval: 19951000
These highlights do not include all the information needed to use Omeprazole delayed-release capsules safely and effectively. See full prescribing information for Omeprazole delayed-release capsules. OMEPRAZOLE delayed-release capsules, USP, for oral use Initial U.S. Approval: 198923
These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 19951001
CEPHALEXIN CAPSULES, USP8
These highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP. FLUOXETINE Capsules, USP for Oral Use Initial U.S. Approval: 198715
GABAPENTIN CAPSULES, USP Rx only5
CLARAVIS™ (isotretinoin capsules USP)4
LITHIUM CARBONATE Tablets USP LITHIUM CARBONATE Capsules USP LITHIUM Oral Solution USP13
Zonisamide Capsules11
GABAPENTIN CAPSULES, USP 40-9155 Revised — September 2011 Rx only27
c70b5045-706e-443a-9be1-d0bc3c5981304
Bisacodyl Enteric Coated Tablet7
Terazosin Hydrochloride Capsules6
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES 7384 7385 7386 Rx only6
Verapamil Hydrochloride Sustained-Release Capsules1000
80b7007e-be26-4388-8d62-9541baf75c6b1000
These highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 19595
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use omeprazole safely and effectively. See full prescribing information for omeprazole. OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP "Initial U.S. Approval:".19896
d6a161d9-7e7a-4711-ba0e-c9040c42268d5
b3180408-a3c0-4e02-8535-dea390a522777
Triamterene and Hydrochlorothiazide Capsules, USP6
Chlorpromazine Hydrochloride Tablets, USP4
These highlights do not include all the information needed to use Amlodipine Besylate and Benazepril Hydrochloride Capsules safely and effectively. See full prescribing information for Amlodipine Besylate and Benazepril Hydrochloride Capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 19955
These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 20045
Amoxicillin Capsules, Tablets and Powder for Oral Suspension, USP6
These highlights do not include all the information needed to use lansoprazole delayed-release capsules USP safely and effectively. See full prescribing information for lansoprazole delayed-release capsules USP. LANSOPRAZOLE delayed-release capsules USP for oral use Initial U.S. Approval: 19954
Lithium Carbonate Capsules USP Rx Only6
These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 20043362
Indomethacin Extended – Release Capsules, USP 75 mg3231
These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. Initial U.S. Approval: 19879
Strazepam17
Fluoxetine 10 mg These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. Initial U.S. Approval: 19879
Fluoxetine 10 mg These highlights do not include all the information needed to use fluoxetine capsules USP safely and effectively. See full prescribing information for fluoxetine capsules USP. Initial U.S. Approval: 19878
HYDROXYZINE PAMOATE Capsules USP5
AMOXICILLIN CAPSULES USP, 250 mg and 500 mg/ AMOXICILLIN FOR ORAL SUSPENSION USP, 125 mg per 5 mL and 250 mg per 5 mL/AMOXICILLIN TABLETS USP (CHEWABLE), 125 mg and 250 mg 3107 3109 2267 2268 4150 4155 Rx only10
These highlights do not include all the information needed to use Calcium Acetate Capsules safely and effectively. See full prescribing information for Calcium Acetate Capsules. Calcium Acetate Capsules, 667 mg Initial U.S. Approval: 19907
LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY, DBA QUALITY CARE PRODUCTS, LLC]3996
DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3983
FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3978
TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3945
NITROFURANTOIN (MACROCRYSTALS) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3922
INDOMETHACIN CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3911
MEXILETINE HYDROCHLORIDE CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3749
DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3744
OMEPRAZOLE CAPSULE, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3741
NITROFURANTOIN MACROCRYSTALS CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3740
DOXEPIN HYDROCHLORIDE CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3724
LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3671
ETODOLAC CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALTIY CARE PRODUCTS LLC]3619
DOXEPIN HYDROCHLORIDE CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3616
TEMAZEPAM CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3561
LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3544
LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3535
INDOMETHACIN CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3369
LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3363
TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3040
FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3024
DIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1002
TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
LYRICA (PREGABALIN) CAPSULE [BRYANT RANCH PREPACK]1001
LYRICA (PREGABALIN) CAPSULE [BRYANT RANCH PREPACK]1001
NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
AFEDITAB CR (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
DOXEPIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
KADIAN (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
LORATADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
LYRICA (PREGABALIN) CAPSULE [BRYANT RANCH PREPACK]1000
LYRICA (PREGABALIN) CAPSULE [BRYANT RANCH PREPACK]1000
LYRICA (PREGABALIN) CAPSULE [BRYANT RANCH PREPACK]1000
NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, SUGAR COATED [BRYANT RANCH PREPACK]1000
PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
PHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
VERELAN PM (VERAPAMIL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
DOXEPIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC. ]166
FLUOXETINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC. ]162
DOXEPIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC. ]155
CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [REMEDYREPACK INC. ]151
CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED [REMEDYREPACK INC. ]150
DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [REMEDYREPACK INC. ]145
DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE) CAPSULE [REMEDYREPACK INC. ]126
INDOMETHACIN (INDOMETHACIN) CAPSULE [REMEDYREPACK INC. ]125
CALCIUM ACETATE (CALCIUM ACETATE) CAPSULE [REMEDYREPACK INC. ]79
TERAZOSIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC. ]77
DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]36
VICTRELIS (BOCEPREVIR) CAPSULE [MERCK SHARP & DOHME CORP.]33

Inactive Ingredient Database#

Browse recovered IID releases and source provenance.

Current IID rows for UNII 46N107B71O page 1 of 1 · 13 matching rows.

Ingredient, UNII, CAS table
IngredientUNIICASDosage formRoutePotencyMaximum daily exposure
SHELLAC46N107B71O9000593CAPSULEORAL34.48 mg
SHELLAC46N107B71O9000593CAPSULE, COATED PELLETSORAL29 mg
SHELLAC46N107B71O9000593CAPSULE, COATED, EXTENDED RELEASEORALNA
SHELLAC46N107B71O9000593CAPSULE, DELAYED RELEASEORAL1 mg
SHELLAC46N107B71O9000593CAPSULE, EXTENDED RELEASEORAL75.01 mg
SHELLAC46N107B71O9000593SUSPENSIONORAL3 mg/1ml
SHELLAC46N107B71O9000593TABLETORAL112 mg
SHELLAC46N107B71O9000593TABLET, COATEDORAL30 mg
SHELLAC46N107B71O9000593TABLET, DELAYED RELEASEORAL8 mg
SHELLAC46N107B71O9000593TABLET, EXTENDED RELEASEORAL213.24 mg
SHELLAC46N107B71O9000593TABLET, FILM COATEDORAL4.4 mg
SHELLAC46N107B71O9000593TABLET, SUGAR COATEDORALNA
SHELLAC46N107B71O9000593FILMSUBLINGUALNA