FDA.reportPublic FDA data

AZITHROMYCIN MONOHYDRATE

Substance profile for UNII JTE4MNN1MD, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for AZITHROMYCIN MONOHYDRATE
Structure render from PubChem CID 9897015

Substance Identity#

UNII
JTE4MNN1MD
Preferred term
AZITHROMYCIN MONOHYDRATE
Registry number
121470-24-4
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C38H72N2O12.H2O
Chemical structure for AZITHROMYCIN MONOHYDRATE
Structure render from PubChem CID 9897015

Chemical And Database Identifiers#

InChIKey
HQUPLSLYZHKKQT-WVVFQGGUSA-N
SMILES
O.CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]3O[C@H](C)C[C@@H]([C@H]3O)N(C)C)[C@](C)(O)C[C@@H](C)CN(C)[C@H](C)[C@@H](O)[C@]1(C)O
RxCUI
1298839
PubChem
9897015
NCIt
C76215
INN ID
0

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound9897015https://pubchem.ncbi.nlm.nih.gov/compound/9897015
PubChem InChIKey SearchHQUPLSLYZHKKQT-WVVFQGGUSA-Nhttps://pubchem.ncbi.nlm.nih.gov/#query=HQUPLSLYZHKKQT-WVVFQGGUSA-N
RxNorm1298839https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1298839
NCI ThesaurusC76215https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C76215
FDA Substance Registration SystemJTE4MNN1MDhttps://precision.fda.gov/uniisearch/srs/unii/JTE4MNN1MD

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDThese highlights do not include all the information needed to use azithromycin tablets safely and effectively. See full prescribing information for azithromycin tablets . AZITHROMYCIN tablets USP for oral use Initial U.S. Approval: 19911
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN3
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN MONOHYDRATE5
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAzithromycin Tablets, USP1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAzithromycin for Oral Suspension USP 7148 7149 Rx only1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAzithromycin Tablets USP, 250 mg and 500 mg 7146 7169 Rx only1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLETS USP, 250 mg and 500 mg 7146 7169 Rx only1
azithromycin monohydrateACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN FOR ORAL SUSPENSION, USP 7148 7149 Rx only2
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3901
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]20
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]17
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]17
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]17
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]16
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [SANDOZ INC]16
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]15
azithromycin monohydrateACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]12
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]12
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]10
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]8
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]7
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]6
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN MONOHYDRATE TABLET [LUPIN PHARMACEUTICALS, INC.]6
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [CARDINAL HEALTH]6
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]5
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED ]5
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CARDINAL HEALTH]4
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PLIVA INC.]4
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN MONOHYDRATE TABLET [LUPIN PHARMACEUTICALS, INC.]4
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]3
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]3
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]3
Azithromycin MonohydrateACTIVE INGREDIENTJTE4MNN1MDAZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.]2
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CARDINAL HEALTH]2
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) TABLET, FILM COATED [REMEDYREPACK INC. ]2
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AUROMEDICS PHARMA LLC]2
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC. ]2
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN FOR INJECTION INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION) INJECTION [APOTEX CORP.]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CARDINAL HEALTH]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN POWDER, FOR SUSPENSION [CLINICAL SOLUTIONS WHOLESALE]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC. ]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC. ]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC. ]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC. ]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC. ]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC. ]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC. ]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC. ]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC. ]1
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC. ]1