Home NDC 0093-7146 Azithromycin
Product NDC 0093-7146
11-digit product format 000937146
Labeler code 0093
Product ID 0093-7146_663c9c2a-f6ce-43e4-b229-1f3328dd24a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azithromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA,
Application ANDA065153
Marketing category ANDA
Marketing start 2005-11-16
Marketing end 2020-03-31
Substance AZITHROMYCIN MO
Active strength 250 mg/1
Pharmacologic classes Macrolide Antim
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065153-001 AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL AB 2005-11-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065153-001 AZITHROMYCIN EQ 250MG BASE TABLET / ORAL 2005-11-14 f41ea6bd6efb…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-07-19 19:46 UTC 2019-07 A065153-001 AB 1 ea99ee380514…
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AZITHROMYCIN MONOHYDRATE ACTIVE INGREDIENT JTE4MNN1MD AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 ANHYDROUS DIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT L11K75P92J AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 COCHINEAL INACTIVE INGREDIENT TZ8Z31B35M AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES] 2 AZITHROMYCIN MONOHYDRATE ACTIVE INGREDIENT JTE4MNN1MD AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 AZITHROMYCIN MONOHYDRATE ACTIVE INGREDIENT JTE4MNN1MD AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 AZITHROMYCIN ACTIVE MOIETY F94OW58Y8V AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 AZITHROMYCIN ANHYDROUS ACTIVE MOIETY J2KLZ20U1M AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 ANHYDROUS DIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT L11K75P92J AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 COCHINEAL INACTIVE INGREDIENT TZ8Z31B35M AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 COCHINEAL INACTIVE INGREDIENT TZ8Z31B35M AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 AZITHROMYCIN TABLET, FILM COATED [MEDVANTX, INC.] 1
DailyMed RxNorm Mappings#