Azithromycin

Product NDC
50111-787
11-digit product format
501110787
Labeler code
50111
Product ID
50111-787_96661456-78d1-48f2-bcd9-ceb3a8437387
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA065225
Marketing category
ANDA
Marketing start
2006-01-06
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065225-001AZITHROMYCINAZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A065225-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-143f01610625f2…
2019-09-15 20:21 UTC2019-09A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065225-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2005-11-14cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065225-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065225-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065225-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065225-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065225-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065225-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065225-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065225-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065225-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065225-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065225-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065225-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065225-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065225-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065225-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065225-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065225-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065225-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065225-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065225-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065225-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065225-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065225-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065225-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065225-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065225-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065225-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065225-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065225-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065225-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065225-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065225-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065225-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065225-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065225-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065225-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065225-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065225-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065225-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065225-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN MONOHYDRATE250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JTE4MNN1MDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
248656Internal RxNorm lookup
308460Internal RxNorm lookup
749780Internal RxNorm lookup
749783Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f6a52c0b-45db-422e-8c22-e867a11b4439Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50111-787-10Azithromycin30 in 1 BOTTLETABLET, FILM COATED3022
50111-787-51Azithromycin1 in 1 CARTONTABLET, FILM COATED122
50111-787-51Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED622
50111-787-66Azithromycin3 in 1 PACKAGETABLET, FILM COATED322
50111-787-66Azithromycin1 in 1 CARTONTABLET, FILM COATED122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50111-787-10EA - Each50111-787f2bf0176-f48a-4e90-b10e-f6fb2fda516b12017-10-13
50111-787-51EA - Each50111-7878e64b23d-999c-4945-8291-00bd18d54d6312013-02-13
50111-787-66EA - Each50111-78759338e67-5e55-49e4-8ac2-d7f759ede6c912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]10
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX]5
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50111-787AZITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]21Current NDC, Legacy NDC, 5 package rows20230807_f6a52c0b-45db-422e-8c22-e867a11b4439.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzithromycinAZITHROMYCINREMEDYREPACK INC.333ffe63-aaeb-4dff-b595-1c11209189a62026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065225
application number: ANDA065225
AzithromycinAZITHROMYCINSportpharm LLC5f9e13f5-69ee-4220-90d9-31fa8660d8802026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065225
application number: ANDA065225
AzithromycinAZITHROMYCINAdvanced Rx Pharmacy of Tennessee, LLCf175496a-4ad3-ce0d-e053-2a95a90a66132024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065225
application number: ANDA065225
AzithromycinAZITHROMYCINAsclemed USA, Inc.9c44af6d-8a9a-cb4c-e053-2a95a90afdac2023-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065225
application number: ANDA065225
AzithromycinAZITHROMYCINTeva Pharmaceuticals USA, Inc.f6a52c0b-45db-422e-8c22-e867a11b44392023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065225
application number: ANDA065225
ndc (product): 50111-787
AzithromycinAZITHROMYCIN MONOHYDRATEPharmPak, Inc.ba57ff26-cd02-4f57-ac92-b613d245a4ea2022-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065225
application number: ANDA065225
AzithromycinAZITHROMYCINProficient Rx LP7e7c2f49-449c-4ba2-98ae-0ff0c040614c2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065225
application number: ANDA065225

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKf6a52c0b-45db-422e-8c22-e867a11b443922
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKf6a52c0b-45db-422e-8c22-e867a11b443922
308460azithromycin 250 MG Oral TabletPSNf6a52c0b-45db-422e-8c22-e867a11b443922
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNf6a52c0b-45db-422e-8c22-e867a11b443922
248656azithromycin 500 MG Oral TabletPSNf6a52c0b-45db-422e-8c22-e867a11b443922
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNf6a52c0b-45db-422e-8c22-e867a11b443922
308460azithromycin 250 MG Oral TabletSCDf6a52c0b-45db-422e-8c22-e867a11b443922
248656azithromycin 500 MG Oral TabletSCDf6a52c0b-45db-422e-8c22-e867a11b443922
749783azithromycin 250 MG Oral Tablet 6 Count PackSYf6a52c0b-45db-422e-8c22-e867a11b443922
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYf6a52c0b-45db-422e-8c22-e867a11b443922
749780azithromycin 500 MG Oral Tablet 3 Count PackSYf6a52c0b-45db-422e-8c22-e867a11b443922
308460azithromycin 250 MG Oral TabletPSN333ffe63-aaeb-4dff-b595-1c11209189a617
308460azithromycin 250 MG Oral TabletSCD333ffe63-aaeb-4dff-b595-1c11209189a617
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK7e7c2f49-449c-4ba2-98ae-0ff0c040614c8
308460azithromycin 250 MG Oral TabletPSN7e7c2f49-449c-4ba2-98ae-0ff0c040614c8
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN7e7c2f49-449c-4ba2-98ae-0ff0c040614c8
248656azithromycin 500 MG Oral TabletPSN7e7c2f49-449c-4ba2-98ae-0ff0c040614c8
308460azithromycin 250 MG Oral TabletSCD7e7c2f49-449c-4ba2-98ae-0ff0c040614c8
248656azithromycin 500 MG Oral TabletSCD7e7c2f49-449c-4ba2-98ae-0ff0c040614c8
749783azithromycin 250 MG Oral Tablet 6 Count PackSY7e7c2f49-449c-4ba2-98ae-0ff0c040614c8
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY7e7c2f49-449c-4ba2-98ae-0ff0c040614c8
308460azithromycin 250 MG Oral TabletPSN2c8c977f-6acf-40f9-8a5b-253eb0188ed27
248656azithromycin 500 MG Oral TabletPSN2c8c977f-6acf-40f9-8a5b-253eb0188ed27
308460azithromycin 250 MG Oral TabletSCD2c8c977f-6acf-40f9-8a5b-253eb0188ed27
248656azithromycin 500 MG Oral TabletSCD2c8c977f-6acf-40f9-8a5b-253eb0188ed27
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY2c8c977f-6acf-40f9-8a5b-253eb0188ed27
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK884d8dfb-980a-4bf9-aacd-7eba6373315b5
308460azithromycin 250 MG Oral TabletPSNcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
308460azithromycin 250 MG Oral TabletPSN884d8dfb-980a-4bf9-aacd-7eba6373315b5
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN884d8dfb-980a-4bf9-aacd-7eba6373315b5
248656azithromycin 500 MG Oral TabletPSNcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
308460azithromycin 250 MG Oral TabletSCDcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
308460azithromycin 250 MG Oral TabletSCD884d8dfb-980a-4bf9-aacd-7eba6373315b5
248656azithromycin 500 MG Oral TabletSCDcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
749783azithromycin 250 MG Oral Tablet 6 Count PackSY884d8dfb-980a-4bf9-aacd-7eba6373315b5
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
749780azithromycin 500 MG Oral Tablet 3 Count PackSYcd108535-4bc5-4d5b-a3c1-6fb9f533194d5
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK84aa116a-4aae-4e91-801f-1c5ced73ddce4
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK77f12139-2e38-4298-b4f4-c24976cf06364
308460azithromycin 250 MG Oral TabletPSN84aa116a-4aae-4e91-801f-1c5ced73ddce4
308460azithromycin 250 MG Oral TabletPSN77f12139-2e38-4298-b4f4-c24976cf06364
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN84aa116a-4aae-4e91-801f-1c5ced73ddce4
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN77f12139-2e38-4298-b4f4-c24976cf06364
248656azithromycin 500 MG Oral TabletPSN77f12139-2e38-4298-b4f4-c24976cf06364
308460azithromycin 250 MG Oral TabletSCD84aa116a-4aae-4e91-801f-1c5ced73ddce4
308460azithromycin 250 MG Oral TabletSCD77f12139-2e38-4298-b4f4-c24976cf06364
248656azithromycin 500 MG Oral TabletSCD77f12139-2e38-4298-b4f4-c24976cf06364
749783azithromycin 250 MG Oral Tablet 6 Count PackSY84aa116a-4aae-4e91-801f-1c5ced73ddce4
749783azithromycin 250 MG Oral Tablet 6 Count PackSY77f12139-2e38-4298-b4f4-c24976cf06364
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY77f12139-2e38-4298-b4f4-c24976cf06364
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKf175496a-4ad3-ce0d-e053-2a95a90a66133
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKf454c421-ebbe-4a58-b9fa-000dab90a6e03
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK5f9e13f5-69ee-4220-90d9-31fa8660d8803
308460azithromycin 250 MG Oral TabletPSNf454c421-ebbe-4a58-b9fa-000dab90a6e03
308460azithromycin 250 MG Oral TabletPSNf175496a-4ad3-ce0d-e053-2a95a90a66133
308460azithromycin 250 MG Oral TabletPSN5f9e13f5-69ee-4220-90d9-31fa8660d8803
308460azithromycin 250 MG Oral TabletPSN9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNf175496a-4ad3-ce0d-e053-2a95a90a66133
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN5f9e13f5-69ee-4220-90d9-31fa8660d8803
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNf454c421-ebbe-4a58-b9fa-000dab90a6e03
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
248656azithromycin 500 MG Oral TabletPSN9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
308460azithromycin 250 MG Oral TabletSCD5f9e13f5-69ee-4220-90d9-31fa8660d8803
308460azithromycin 250 MG Oral TabletSCD9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
308460azithromycin 250 MG Oral TabletSCDf454c421-ebbe-4a58-b9fa-000dab90a6e03
308460azithromycin 250 MG Oral TabletSCDf175496a-4ad3-ce0d-e053-2a95a90a66133
248656azithromycin 500 MG Oral TabletSCD9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
749783azithromycin 250 MG Oral Tablet 6 Count PackSYf454c421-ebbe-4a58-b9fa-000dab90a6e03
749783azithromycin 250 MG Oral Tablet 6 Count PackSYf175496a-4ad3-ce0d-e053-2a95a90a66133
749783azithromycin 250 MG Oral Tablet 6 Count PackSY9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
749783azithromycin 250 MG Oral Tablet 6 Count PackSY5f9e13f5-69ee-4220-90d9-31fa8660d8803
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
749780azithromycin 500 MG Oral Tablet 3 Count PackSY9c44af6d-8a9a-cb4c-e053-2a95a90afdac3
308460azithromycin 250 MG Oral TabletPSNc6c94568-1e3c-494a-893b-e84f019cc5fc2
308460azithromycin 250 MG Oral TabletPSNbb23de1f-6c42-4b36-a840-a377f50826832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50111-787-105011107871030 TABLET, FILM COATED in 1 BOTTLE (50111-787-10) 2006-01-060000-00-00NoNoCurrent
50111-787-51501110787511 BLISTER PACK in 1 CARTON (50111-787-51) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2006-01-060000-00-00NoNoCurrent
50111-787-66501110787663 CARTON in 1 PACKAGE (50111-787-66) / 1 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK3 carton2006-01-060000-00-00NoNoCurrent