Azithromycin monohydrate

Product NDC: 68083-199
11-digit product format: 680830199
Labeler code: 68083
Product ID: 68083-199_d0a507c6-cb4b-4295-bf17-48bb8e4b03f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin monohydrate
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Gland Pharma Limited
Application: ANDA065501
Marketing category: ANDA
Marketing start: 2009-11-09
Substance: AZITHROMYCIN MONOHYDRATE
Active strength: 500 mg/10mL
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
A065501-001	AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2009-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065501-001	AP

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	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`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	A065501-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065501-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065501-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065501-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065501-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065501-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065501-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065501-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065501-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065501-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065501-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065501-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065501-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065501-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065501-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065501-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065501-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065501-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065501-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065501-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065501-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065501-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065501-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065501-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065501-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065501-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065501-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065501-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065501-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065501-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065501-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065501-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065501-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065501-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065501-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065501-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065501-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065501-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065501-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065501-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZITHROMYCIN MONOHYDRATE	500 mg/10mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1668238	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
55051e03-b6dc-4bc6-87c1-e4fb84b61fa3	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	Strength	SPL version
68083-199-10	Azithromycin monohydrate	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		17
68083-199-10	Azithromycin monohydrate	10 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	10		17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AZITHROMYCIN MONOHYDRATE	ACTIVE INGREDIENT	JTE4MNN1MD	AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED ]	5
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED ]	5
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED ]	5
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED ]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-199	AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]	17	Current NDC, Legacy NDC, 2 package rows	20230214_55051e03-b6dc-4bc6-87c1-e4fb84b61fa3.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN MONOHYDRATE	Sagent Pharmaceuticals	cefbce3f-3e6c-4659-abd7-3ec3e8227737	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065501 application number: ANDA065501
Azithromycin	AZITHROMYCIN MONOHYDRATE	Athenex Pharmaceutical Division, LLC.	610a34ea-6aa7-4b94-a85a-ff16ca537d03	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065501 application number: ANDA065501
Azithromycin	AZITHROMYCIN MONOHYDRATE	Athenex Pharmaceutical Division, LLC.	324330c5-20fe-4b22-adf2-14a6e91e71ef	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065501 application number: ANDA065501
Azithromycin	AZITHROMYCIN MONOHYDRATE	Sagent Pharmaceuticals	6497fb5e-82d8-4411-b994-7ee01333ffd7	2024-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065501 application number: ANDA065501
Azithromycin monohydrate	AZITHROMYCIN MONOHYDRATE	Sun Pharmaceutical Industries Limited	c8d012c4-f411-4484-a618-7597599ea621	2023-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065501 application number: ANDA065501
Azithromycin monohydrate	AZITHROMYCIN MONOHYDRATE	Gland Pharma Limited	55051e03-b6dc-4bc6-87c1-e4fb84b61fa3	2022-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065501 application number: ANDA065501 ndc (product): 68083-199

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
1668238	azithromycin 500 MG Injection	PSN	55051e03-b6dc-4bc6-87c1-e4fb84b61fa3	17
1668238	azithromycin 500 MG Injection	SCD	55051e03-b6dc-4bc6-87c1-e4fb84b61fa3	17
1668238	azithromycin (as azithromycin dihydrate) 500 MG Injection	SY	55051e03-b6dc-4bc6-87c1-e4fb84b61fa3	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-199-10	68083019910	10 VIAL in 1 CARTON (68083-199-10) / 10 mL in 1 VIAL	10 vial	2009-11-09	0000-00-00	No	No	Current