FDA.reportPublic FDA data

Azithromycin

Product NDC
64679-961
11-digit product format
646790961
Labeler code
64679
Product ID
64679-961_d2a1950b-4358-ad27-e053-2a95a90a7f92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA065404
Marketing category
ANDA
Marketing start
2008-02-11
Marketing end
0000-00-00
Substance
AZITHROMYCIN ANHYDROUS
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64679-961-012024-11-14C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-961-022024-11-14C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-961-052024-11-14C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-961-072024-11-14C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-961-082024-11-14C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-961-012023-01-30C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-961-022023-01-30C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-961-052023-01-30C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-961-072023-01-30C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc
64679-961-082023-01-30C16284748780-1f386c64a-2c86-0266-e053-dadaa90a7c1accf371e5-268c-4a89-a39b-4ca25e5035fc

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-961-01EA - Each64679-961644a2175-b839-428f-8572-d3c75e30d23512012-07-24
64679-961-02EA - Each64679-961d5e1d78d-7318-4405-9102-e13380aa2a3c12022-04-06
64679-961-04EA - Each64679-961b71506f1-f812-4bc6-b634-85425fc2028d12012-07-24
64679-961-05EA - Each64679-961d87c8206-1f44-470e-92a8-685622ffd91312012-07-24
64679-961-07EA - Each64679-961f0dc0378-b555-46df-bfab-188c80a5e7d212012-07-24
64679-961-08EA - Each64679-961e93d0680-275d-4470-aa16-f2f7070b30c212022-04-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [RXCHANGE CO.]2
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [RXCHANGE CO.]2
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSN7e6e1d06-5a28-4064-9bad-1c0303f5d5558
308460azithromycin 250 MG Oral TabletSCD7e6e1d06-5a28-4064-9bad-1c0303f5d5558
308460azithromycin 250 MG Oral TabletPSN85ff97e4-f161-4570-aa75-4b0dc4076e8f6
308460azithromycin 250 MG Oral TabletSCD85ff97e4-f161-4570-aa75-4b0dc4076e8f6
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK6c4ce016-e728-4d9a-b1c9-ffd2a8d156072
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK6307a49b-753a-4232-a51d-bf6d0537b05b2
308460azithromycin 250 MG Oral TabletPSN330a082d-57b2-2bf5-e054-00144ff88e882
308460azithromycin 250 MG Oral TabletPSN6c4ce016-e728-4d9a-b1c9-ffd2a8d156072
308460azithromycin 250 MG Oral TabletPSN6307a49b-753a-4232-a51d-bf6d0537b05b2
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN6307a49b-753a-4232-a51d-bf6d0537b05b2
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN6c4ce016-e728-4d9a-b1c9-ffd2a8d156072
212446Zithromax 250 MG Oral TabletPSN330a082d-57b2-2bf5-e054-00144ff88e882
212446azithromycin 250 MG Oral Tablet [Zithromax]SBD330a082d-57b2-2bf5-e054-00144ff88e882
308460azithromycin 250 MG Oral TabletSCD6307a49b-753a-4232-a51d-bf6d0537b05b2
308460azithromycin 250 MG Oral TabletSCD6c4ce016-e728-4d9a-b1c9-ffd2a8d156072
308460azithromycin 250 MG Oral TabletSCD330a082d-57b2-2bf5-e054-00144ff88e882
749783azithromycin 250 MG Oral Tablet 6 Count PackSY6307a49b-753a-4232-a51d-bf6d0537b05b2
749783azithromycin 250 MG Oral Tablet 6 Count PackSY6c4ce016-e728-4d9a-b1c9-ffd2a8d156072
212446Zithromax 250 MG Oral TabletSY330a082d-57b2-2bf5-e054-00144ff88e882
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKeeea2ed3-ae33-4e88-abdf-dfcf85582d461
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKeeea2ed3-ae33-4e88-abdf-dfcf85582d461
308460azithromycin 250 MG Oral TabletPSN6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
308460azithromycin 250 MG Oral TabletPSN9e5bb949-c9be-48cd-b0a2-6b7fd536e7771
308460azithromycin 250 MG Oral TabletPSNeeea2ed3-ae33-4e88-abdf-dfcf85582d461
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNeeea2ed3-ae33-4e88-abdf-dfcf85582d461
248656azithromycin 500 MG Oral TabletPSN6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
248656azithromycin 500 MG Oral TabletPSNeeea2ed3-ae33-4e88-abdf-dfcf85582d461
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNeeea2ed3-ae33-4e88-abdf-dfcf85582d461
308460azithromycin 250 MG Oral TabletSCD6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
308460azithromycin 250 MG Oral TabletSCD9e5bb949-c9be-48cd-b0a2-6b7fd536e7771
308460azithromycin 250 MG Oral TabletSCDeeea2ed3-ae33-4e88-abdf-dfcf85582d461
248656azithromycin 500 MG Oral TabletSCDeeea2ed3-ae33-4e88-abdf-dfcf85582d461
248656azithromycin 500 MG Oral TabletSCD6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
749783azithromycin 250 MG Oral Tablet 6 Count PackSYeeea2ed3-ae33-4e88-abdf-dfcf85582d461
749783azithromycin 250 MG Oral Tablet 6 Count PackSY6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY6fadde9e-dab3-4d01-b3fb-795eef7eff2f1
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYeeea2ed3-ae33-4e88-abdf-dfcf85582d461
749780azithromycin 500 MG Oral Tablet 3 Count PackSYeeea2ed3-ae33-4e88-abdf-dfcf85582d461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-961-016467909610130 TABLET, FILM COATED in 1 BOTTLE (64679-961-01) 2015-07-280000-00-00NoNoCurrent
64679-961-026467909610210 BLISTER PACK in 1 CARTON (64679-961-02) > 10 TABLET, FILM COATED in 1 BLISTER PACK (64679-961-09) 10 blister pack2015-07-280000-00-00NoNoCurrent
64679-961-05646790961053 BLISTER PACK in 1 CARTON (64679-961-05) > 6 TABLET, FILM COATED in 1 BLISTER PACK (64679-961-04) 3 blister pack2015-07-280000-00-00NoNoCurrent
64679-961-0764679096107500 TABLET, FILM COATED in 1 BOTTLE (64679-961-07) 2015-07-280000-00-00NoNoCurrent
64679-961-08646790961083500 TABLET, FILM COATED in 1 BAG (64679-961-08) 2015-07-280000-00-00NoNoCurrent