Azithromycin Dihydrate

Product NDC: 83008-081
11-digit product format: 830080081
Labeler code: 83008
Product ID: 83008-081_ba400da0-efae-451a-91d4-b9f5ad4dc773
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin Dihydrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA208250
Marketing category: ANDA
Marketing start: 2024-08-28
Marketing end: 2027-01-02
Substance: AZITHROMYCIN DIHYDRATE
Active strength: 250 mg/1
Pharmacologic classes: Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag: No
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
A208250-001	AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB		2019-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208250-001	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.

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
2026-08-01 22:54:32	2026-06	A208250-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB		2019-04-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A208250-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	PD-Rx Pharmaceuticals, Inc.	7ab854bf-eb04-42c4-a403-096b60581bb4	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Precision Dose, Inc.	d9b66736-3f1a-4d6d-bdc4-274f5adfb40c	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	a5b4092d-ab72-f5d1-e053-2995a90ac582	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	REMEDYREPACK INC.	f0cfda1a-910f-4764-8658-263037df5ea8	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Preferred Pharmaceuticals Inc.	b3c84aea-7ba7-4aae-999c-db740a9e53df	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	AvPAK	b635019e-7fd4-7f9e-e053-2a95a90a388c	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Redpharm Drug	44f52ce0-ad3f-7d80-e063-6294a90ad086	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	A-S Medication Solutions	df9b39b7-d42d-4c4b-b492-9fd228978dec	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	PD-Rx Pharmaceuticals, Inc.	e9800bbe-e8bf-4689-a8a5-dc23b5d2ee56	2025-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	TAGI Pharma, Inc.	9f0501bf-d1c4-46a5-b253-3b9e61015e82	2025-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Coupler LLC	2cc99fae-a72c-8893-e063-6394a90aa3ef	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Proficient Rx LP	a8e106cb-7245-45a5-9aad-bd624b1e011d	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Advanced Rx Pharmacy of Tennessee, LLC	f1752913-85ac-01fa-e053-2995a90a2bd8	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	NuCare Pharmaceuticals Inc.	258dd3c5-dce9-7483-e063-6294a90a4043	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Quality Care Products, LLC	2065c4ba-e3f5-41a2-b3d5-205dab646924	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250 ndc (product): 83008-081
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	A-S Medication Solutions	1c84a68b-3eaa-4dab-b5e5-e195c7652e67	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Proficient Rx LP	8037c6f4-4881-4740-8229-2aee56141cd0	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	Asclemed USA, Inc.	b08bd8fc-20da-4623-9211-ae669452b16d	2020-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208250 application number: ANDA208250

Additional Listing Data#

Finished product: Yes
Brand name base: Azithromycin Dihydrate

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZITHROMYCIN DIHYDRATE	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5FD1131I7S	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308460	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
2065c4ba-e3f5-41a2-b3d5-205dab646924	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401	Product name	9	20200616
a2cbe82e-b432-4f71-954b-75e9214e8567	Product name	3	20200612
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
371533fa-efb3-4c48-b5e4-60179db407f3	Product name	3	20190124
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83008-081-06	Azithromycin Dihydrate	1 in 1 CARTON	TABLET, FILM COATED	1		4
83008-081-06	Azithromycin Dihydrate	6 in 1 BLISTER PACK	TABLET, FILM COATED	6		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83008-081-06	EA - Each	83008-081	372f886f-2541-46e9-87d0-789103d6fbb9	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83008-081	AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [QUALITY CARE PRODUCTS, LLC]	4	Current NDC, 2 package rows	20241222_2065c4ba-e3f5-41a2-b3d5-205dab646924.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5FD1131I7S	AZITHROMYCIN DIHYDRATE	117772-70-0	AZITHROMYCIN DIHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	2065c4ba-e3f5-41a2-b3d5-205dab646924	4
308460	azithromycin 250 MG Oral Tablet	PSN	2065c4ba-e3f5-41a2-b3d5-205dab646924	4
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	2065c4ba-e3f5-41a2-b3d5-205dab646924	4
308460	azithromycin 250 MG Oral Tablet	SCD	2065c4ba-e3f5-41a2-b3d5-205dab646924	4
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	2065c4ba-e3f5-41a2-b3d5-205dab646924	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
83008-081-06	83008008106	1 BLISTER PACK in 1 CARTON (83008-081-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2024-08-28	2027-01-02	No	No	Historical