Azithromycin

Product NDC: 50111-788
11-digit product format: 501110788
Labeler code: 50111
Product ID: 50111-788_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: ANDA065223
Marketing category: ANDA
Marketing start: 2006-01-06
Substance: AZITHROMYCIN MONOHYDRATE
Active strength: 500 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065223-001	AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB		2005-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065223-001	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065223-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065223-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065223-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065223-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065223-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065223-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065223-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065223-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065223-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065223-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065223-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065223-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065223-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065223-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065223-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065223-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065223-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065223-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065223-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065223-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065223-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065223-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065223-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065223-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065223-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065223-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065223-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065223-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065223-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065223-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065223-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065223-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065223-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065223-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065223-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065223-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065223-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065223-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065223-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065223-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065223-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZITHROMYCIN MONOHYDRATE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JTE4MNN1MD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f6a52c0b-45db-422e-8c22-e867a11b4439	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401	Product name	9	20200616
a2cbe82e-b432-4f71-954b-75e9214e8567	Product name	3	20200612
371533fa-efb3-4c48-b5e4-60179db407f3	Product name	3	20190124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50111-788-10	Azithromycin	30 in 1 BOTTLE	TABLET, FILM COATED	30	22
50111-788-55	Azithromycin	3 in 1 BLISTER PACK	TABLET, FILM COATED	3	22
50111-788-55	Azithromycin	1 in 1 CARTON	TABLET, FILM COATED	1	22
50111-788-67	Azithromycin	3 in 1 PACKAGE	TABLET, FILM COATED	3	22
50111-788-67	Azithromycin	1 in 1 CARTON	TABLET, FILM COATED	1	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50111-788-10	EA - Each	50111-788	34ba7254-d45a-4b22-acca-b09320ec98e2	1	2017-05-03
50111-788-52	EA - Each	50111-788	7407ce89-89df-40cb-9adb-e7ea1d93987c	1	2013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AZITHROMYCIN MONOHYDRATE	ACTIVE INGREDIENT	JTE4MNN1MD	AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]	10
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]	10
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]	10
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]	10
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]	10
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]	10
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]	10
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]	10
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	AZITHROMYCIN TABLET, FILM COATED [PLIVA, INC.]	10
AZITHROMYCIN MONOHYDRATE	ACTIVE INGREDIENT	JTE4MNN1MD	AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]	2
AZITHROMYCIN MONOHYDRATE	ACTIVE INGREDIENT	JTE4MNN1MD	AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]	2
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]	2
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]	2
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]	2
AZITHROMYCIN MONOHYDRATE	ACTIVE INGREDIENT	JTE4MNN1MD	AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]	1
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]	1
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]	1
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]	1
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	AZITHROMYCIN TABLET, FILM COATED [DIRECTRX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50111-788	AZITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]	21	Current NDC, Legacy NDC, 5 package rows	20230807_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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	943b9246-7733-44b1-875c-91d2ade78ac4	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065223 application number: ANDA065223
Azithromycin	AZITHROMYCIN	Sportpharm LLC	397471e5-76e2-462c-af30-bcc54fe00266	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065223 application number: ANDA065223
Azithromycin	AZITHROMYCIN	Asclemed USA, Inc.	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065223 application number: ANDA065223
Azithromycin	AZITHROMYCIN	Teva Pharmaceuticals USA, Inc.	f6a52c0b-45db-422e-8c22-e867a11b4439	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065223 application number: ANDA065223 ndc (product): 50111-788
Azithromycin	AZITHROMYCIN	Proficient Rx LP	7e7c2f49-449c-4ba2-98ae-0ff0c040614c	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065223 application number: ANDA065223

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JTE4MNN1MD	AZITHROMYCIN MONOHYDRATE	121470-24-4	AZITHROMYCIN MONOHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
749780	{3 (azithromycin 500 MG Oral Tablet) } Pack	GPCK	f6a52c0b-45db-422e-8c22-e867a11b4439	22
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	f6a52c0b-45db-422e-8c22-e867a11b4439	22
308460	azithromycin 250 MG Oral Tablet	PSN	f6a52c0b-45db-422e-8c22-e867a11b4439	22
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	f6a52c0b-45db-422e-8c22-e867a11b4439	22
248656	azithromycin 500 MG Oral Tablet	PSN	f6a52c0b-45db-422e-8c22-e867a11b4439	22
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	PSN	f6a52c0b-45db-422e-8c22-e867a11b4439	22
308460	azithromycin 250 MG Oral Tablet	SCD	f6a52c0b-45db-422e-8c22-e867a11b4439	22
248656	azithromycin 500 MG Oral Tablet	SCD	f6a52c0b-45db-422e-8c22-e867a11b4439	22
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	f6a52c0b-45db-422e-8c22-e867a11b4439	22
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	f6a52c0b-45db-422e-8c22-e867a11b4439	22
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	SY	f6a52c0b-45db-422e-8c22-e867a11b4439	22
248656	azithromycin 500 MG Oral Tablet	PSN	943b9246-7733-44b1-875c-91d2ade78ac4	17
248656	azithromycin 500 MG Oral Tablet	SCD	943b9246-7733-44b1-875c-91d2ade78ac4	17
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	943b9246-7733-44b1-875c-91d2ade78ac4	17
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	7e7c2f49-449c-4ba2-98ae-0ff0c040614c	8
308460	azithromycin 250 MG Oral Tablet	PSN	7e7c2f49-449c-4ba2-98ae-0ff0c040614c	8
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	7e7c2f49-449c-4ba2-98ae-0ff0c040614c	8
248656	azithromycin 500 MG Oral Tablet	PSN	7e7c2f49-449c-4ba2-98ae-0ff0c040614c	8
308460	azithromycin 250 MG Oral Tablet	SCD	7e7c2f49-449c-4ba2-98ae-0ff0c040614c	8
248656	azithromycin 500 MG Oral Tablet	SCD	7e7c2f49-449c-4ba2-98ae-0ff0c040614c	8
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	7e7c2f49-449c-4ba2-98ae-0ff0c040614c	8
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	7e7c2f49-449c-4ba2-98ae-0ff0c040614c	8
308460	azithromycin 250 MG Oral Tablet	PSN	2c8c977f-6acf-40f9-8a5b-253eb0188ed2	7
248656	azithromycin 500 MG Oral Tablet	PSN	2c8c977f-6acf-40f9-8a5b-253eb0188ed2	7
308460	azithromycin 250 MG Oral Tablet	SCD	2c8c977f-6acf-40f9-8a5b-253eb0188ed2	7
248656	azithromycin 500 MG Oral Tablet	SCD	2c8c977f-6acf-40f9-8a5b-253eb0188ed2	7
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	2c8c977f-6acf-40f9-8a5b-253eb0188ed2	7
248656	azithromycin 500 MG Oral Tablet	PSN	334fc377-ab51-418e-ad4b-2a243718095e	6
248656	azithromycin 500 MG Oral Tablet	SCD	334fc377-ab51-418e-ad4b-2a243718095e	6
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	334fc377-ab51-418e-ad4b-2a243718095e	6
749780	{3 (azithromycin 500 MG Oral Tablet) } Pack	GPCK	cd108535-4bc5-4d5b-a3c1-6fb9f533194d	5
308460	azithromycin 250 MG Oral Tablet	PSN	cd108535-4bc5-4d5b-a3c1-6fb9f533194d	5
248656	azithromycin 500 MG Oral Tablet	PSN	cd108535-4bc5-4d5b-a3c1-6fb9f533194d	5
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	PSN	cd108535-4bc5-4d5b-a3c1-6fb9f533194d	5
308460	azithromycin 250 MG Oral Tablet	SCD	cd108535-4bc5-4d5b-a3c1-6fb9f533194d	5
248656	azithromycin 500 MG Oral Tablet	SCD	cd108535-4bc5-4d5b-a3c1-6fb9f533194d	5
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	cd108535-4bc5-4d5b-a3c1-6fb9f533194d	5
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	SY	cd108535-4bc5-4d5b-a3c1-6fb9f533194d	5
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	77f12139-2e38-4298-b4f4-c24976cf0636	4
308460	azithromycin 250 MG Oral Tablet	PSN	77f12139-2e38-4298-b4f4-c24976cf0636	4
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	77f12139-2e38-4298-b4f4-c24976cf0636	4
248656	azithromycin 500 MG Oral Tablet	PSN	77f12139-2e38-4298-b4f4-c24976cf0636	4
308460	azithromycin 250 MG Oral Tablet	SCD	77f12139-2e38-4298-b4f4-c24976cf0636	4
248656	azithromycin 500 MG Oral Tablet	SCD	77f12139-2e38-4298-b4f4-c24976cf0636	4
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	77f12139-2e38-4298-b4f4-c24976cf0636	4
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	77f12139-2e38-4298-b4f4-c24976cf0636	4
749780	{3 (azithromycin 500 MG Oral Tablet) } Pack	GPCK	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
308460	azithromycin 250 MG Oral Tablet	PSN	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
248656	azithromycin 500 MG Oral Tablet	PSN	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	PSN	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
308460	azithromycin 250 MG Oral Tablet	SCD	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
248656	azithromycin 500 MG Oral Tablet	SCD	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	SY	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	3
248656	azithromycin 500 MG Oral Tablet	PSN	ba57ff26-cd02-4f57-ac92-b613d245a4ea	2
248656	azithromycin 500 MG Oral Tablet	PSN	397471e5-76e2-462c-af30-bcc54fe00266	2
248656	azithromycin 500 MG Oral Tablet	SCD	ba57ff26-cd02-4f57-ac92-b613d245a4ea	2
248656	azithromycin 500 MG Oral Tablet	SCD	397471e5-76e2-462c-af30-bcc54fe00266	2
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	ba57ff26-cd02-4f57-ac92-b613d245a4ea	2
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	397471e5-76e2-462c-af30-bcc54fe00266	2
248656	azithromycin 500 MG Oral Tablet	PSN	8c2d65e1-7fa4-49ee-aa12-0322fc303c28	1
248656	azithromycin 500 MG Oral Tablet	SCD	8c2d65e1-7fa4-49ee-aa12-0322fc303c28	1
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	8c2d65e1-7fa4-49ee-aa12-0322fc303c28	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50111-788-10	50111078810	30 TABLET, FILM COATED in 1 BOTTLE (50111-788-10)		2006-01-06	0000-00-00	No	No	Current
50111-788-55	50111078855	1 BLISTER PACK in 1 CARTON (50111-788-55) / 3 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2014-02-18	0000-00-00	No	No	Current
50111-788-67	50111078867	3 CARTON in 1 PACKAGE (50111-788-67) / 1 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK	3 carton	2006-01-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azithromycin	REMEDYREPACK INC.	2026-06-29	HUMAN PRESCRIPTION DRUG LABEL	18
Azithromycin	Sportpharm LLC	2026-04-24	HUMAN PRESCRIPTION DRUG LABEL	2
Azithromycin	NuCare Pharmaceuticals,Inc.	2024-06-14	HUMAN PRESCRIPTION DRUG LABEL	2
Azithromycin	Pharmasource Meds, LLC	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	2
Azithromycin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-09-01	HUMAN PRESCRIPTION DRUG LABEL	3
Azithromycin	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	6
Azithromycin	Teva Pharmaceuticals USA, Inc.	2023-03-01	HUMAN PRESCRIPTION DRUG LABEL	22
Azithromycin	PharmPak, Inc.	2022-10-14	HUMAN PRESCRIPTION DRUG LABEL	2
AZITHROMYCIN Tablets USP 250 mg and 500 mg	Proficient Rx LP	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	8
Azithromycin	NuCare Pharmaceuticals,Inc.	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL	2
Azithromycin	RPK Pharmaceuticals, Inc.	2020-12-15	HUMAN PRESCRIPTION DRUG LABEL	5
Azithromycin	Preferred Pharmaceuticals, Inc.	2019-06-12	HUMAN PRESCRIPTION DRUG LABEL	6
Azithromycin	A-S Medication Solutions	2018-08-28	HUMAN PRESCRIPTION DRUG LABEL	7
Azithromycin	NuCare Pharmaceuticals, Inc.	2017-03-16	HUMAN PRESCRIPTION DRUG LABEL	1
Azithromycin	Aidarex Pharmaceuticals LLC	2017-02-21	HUMAN PRESCRIPTION DRUG LABEL	4
AZITHROMYCIN	DirectRX	2015-11-11	HUMAN PRESCRIPTION DRUG LABEL	1