NDC 50111-788-52 - Azithromycin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 50111-788
Requested NDC: 50111-788-52
Package NDCs from labels: 50111-788-55, 50111-788-67, 50111-788-10, 50111-788-52
Manufacturer: REMEDYREPACK INC.
Effective date: 2026-06-29
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Azithromycin - REMEDYREPACK INC.	REMEDYREPACK INC.	2026-06-29	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - Sportpharm LLC	Sportpharm LLC	2026-04-24	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2024-06-14	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - Pharmasource Meds, LLC	Pharmasource Meds, LLC	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-09-01	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - RPK Pharmaceuticals, Inc.	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - Teva Pharmaceuticals USA, Inc.	Teva Pharmaceuticals USA, Inc.	2023-03-01	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - PharmPak, Inc.	PharmPak, Inc.	2022-10-14	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - Proficient Rx LP	Proficient Rx LP	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - RPK Pharmaceuticals, Inc.	RPK Pharmaceuticals, Inc.	2020-12-15	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - Preferred Pharmaceuticals, Inc.	Preferred Pharmaceuticals, Inc.	2019-06-12	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - A-S Medication Solutions	A-S Medication Solutions	2018-08-28	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - NuCare Pharmaceuticals, Inc.	NuCare Pharmaceuticals, Inc.	2017-03-16	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - Aidarex Pharmaceuticals LLC	Aidarex Pharmaceuticals LLC	2017-02-21	HUMAN PRESCRIPTION DRUG LABEL
AZITHROMYCIN - DirectRX	DirectRX	2015-11-11	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2013-02-11	Indexing - Billing Unit

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 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

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

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 114 · 2,262 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	W Aesthetics	5b0f2c8f-d6fa-5e25-e063-6394a90a084d	2026-09-09	Warnings	Exact identifier unii: 15FIX9V2JP
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	94e17ae5-0871-67a0-e053-2995a90ae0ae	2026-09-09	Warnings, Adverse reactions	Exact identifier rxcui: 248656 unii: 5FD1131I7S
azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	da399401-1ee6-422a-be46-0bba6b264b2f	2026-09-08	Warnings, Adverse reactions	Exact identifier rxcui: 308460 unii: 5FD1131I7S
Azithromycin	AZITHROMYCIN	Aurobindo Pharma Limited	3c902990-b870-4725-b9fe-76b8be633e1c	2026-09-03	Warnings, Adverse reactions	Exact identifier unii: 5FD1131I7S
azithromycin	AZITHROMYCIN	Major Pharmaceuticals	814abe38-da4a-48af-bf4b-2ce04a5aabd1	2026-09-02	Warnings, Adverse reactions	Exact identifier rxcui: 308460 rxcui: 248656 unii: 5FD1131I7S
azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	bf061799-cdef-40f8-b1ce-bc5eb609f8c3	2026-09-02	Warnings, Adverse reactions	Exact identifier rxcui: 248656 unii: 5FD1131I7S
Azithromycin	AZITHROMYCIN	Aurobindo Pharma Limited	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	2026-09-02	Warnings, Adverse reactions	Exact identifier rxcui: 749780 rxcui: 308460 rxcui: 248656 rxcui: 749783 unii: 5FD1131I7S
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	REMEDYREPACK INC.	0d5129e4-8b94-4a4d-baa9-be0d6b32d714	2026-08-31	Warnings, Adverse reactions	Exact identifier unii: 5FD1131I7S
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	REMEDYREPACK INC.	f0cfda1a-910f-4764-8658-263037df5ea8	2026-08-28	Warnings, Adverse reactions	Exact identifier rxcui: 308460 rxcui: 749783 unii: 5FD1131I7S
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50	SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	5a0b4bd2-f6ad-35dc-e063-6294a90a8a66	2026-08-27	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO Hydrating Lightweight Sunscreen	AVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDE	Guangdong Aimu Biological Technology Co., Ltd	59eeaea1-d726-99f3-e063-6394a90aeea3	2026-08-26	Warnings	Exact identifier unii: 15FIX9V2JP
Q Skin Science	SUNSCREEN	International Cosmeceuticals, Inc	59e4c3d0-ee4c-2350-e063-6394a90ac9d2	2026-08-25	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO zinc stick(GREEN)	TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE	Guangzhou Haishi Biological Technology Co., Ltd.	59c70c82-f7ff-9a04-e063-6294a90a7b3d	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	59d74e3f-e3fa-a7a9-e063-6294a90a76e5	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
Sweat Resistant Sunscreen Body Original	TITANIUM DIOXIDE, ZINC OXIDE	Clutch, Inc.	4bbde755-e312-123e-e063-6294a90a467f	2026-08-20	Warnings	Exact identifier unii: 15FIX9V2JP
azithromycin	AZITHROMYCIN	Lupin Pharmaceuticals, Inc.	01649d79-4677-4577-a3e4-e054f3f9fc3b	2026-08-20	Warnings, Adverse reactions	Exact identifier rxcui: 749780 rxcui: 308460 rxcui: 248656 rxcui: 749783 unii: 5FD1131I7S
azithromycin	AZITHROMYCIN	Lupin Pharmaceuticals, Inc.	c9990a1d-5238-403e-9221-72a9314d7b5e	2026-08-20	Warnings, Adverse reactions	Exact identifier unii: 5FD1131I7S
HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN	ZINC OXIDE,TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	4339df13-77d3-31a1-e063-6394a90a5208	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	HAMBLIN DERMATOLOGY	5942e64c-416e-7525-e063-6394a90a2839	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Protect Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Opal Day Spa	5943413a-48e1-0bdf-e063-6294a90a2fff	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.