erythromycin

Product NDC: 50090-1958
11-digit product format: 500901958
Labeler code: 50090
Product ID: 50090-1958_c1d481ba-af9a-43d1-80ed-9db6109fe3ad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: erythromycin
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: A-S Medication Solutions
Application: ANDA062447
Marketing category: ANDA
Marketing start: 2014-05-08
Substance: ERYTHROMYCIN
Active strength: 5 mg/g
Pharmacologic classes: Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [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 42.

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
A062447-001	ERYTHROMYCIN	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26

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 · 42 observed 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
2026-08-18 06:07:40	2026-07	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC			1983-09-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062447-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1983-09-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062447-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062447-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062447-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062447-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062447-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062447-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062447-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062447-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062447-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062447-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062447-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062447-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062447-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062447-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062447-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062447-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062447-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062447-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062447-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062447-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062447-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062447-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062447-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062447-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062447-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062447-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ERYTHROMYCIN	5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
63937KV33D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310149	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
1df12239-6957-4b2c-9e65-e2154eafddd0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d329c2e1-5ae8-4e64-aea0-77ecea3fa1ab	Product name	3	20250717
3b331500-3b74-bd2b-fede-d46839f2f4d5	Product name	6	20240313
fdae2630-eae0-4769-abfd-8f33d5b771b4	Product name	3	20240202
8c898317-b543-1e4e-254f-84cec2f3f57e	Product name	2	20191002
64ae94c0-3212-d73a-92da-9e6dd85c6ebe	Product name	2	20180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9	Product name	2	20170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfa	Product name	1	20170810
57850177-5927-151f-e1fa-7e2ca47f81e5	Product name	1	20140508
8ee71591-1d8f-e24e-242b-bfef131e3168	Product name	1	20140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-1958-0	2023-02-07	C162847	48780-1	f386c649-a88f-0266-e053-dadaa90a7c1a	ERYTHROMYCIN OPHTHALMIC OINTMENT USP STERILE RX ONLY
50090-1958-0	2023-01-30	C162847	48780-1	f386c649-a88f-0266-e053-dadaa90a7c1a	ERYTHROMYCIN OPHTHALMIC OINTMENT USP STERILE RX ONLY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1958-0	erythromycin	1 in 1 CARTON	OINTMENT	1		15
50090-1958-0	erythromycin	3.5 g in 1 TUBE	OINTMENT	3.5		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1958-0	GM - Gram	50090-1958	0acfe329-1ad8-45b3-b486-b2e46a37f90d	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1958	ERYTHROMYCIN OINTMENT [A-S MEDICATION SOLUTIONS]	15	Current NDC, Legacy NDC, 2 package rows	20230208_1df12239-6957-4b2c-9e65-e2154eafddd0.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
erythromycin	ERYTHROMYCIN	NuCare Pharmaceuticals,Inc.	84119a8f-78d1-2882-e053-2a91aa0a6faa	2024-06-14	Adverse reactions	Exact identifier application applno (ANDA): 062447 application number: ANDA062447
erythromycin	ERYTHROMYCIN	Asclemed USA, Inc.	6186510d-62ca-4083-9895-8d028d71b510	2023-09-12	Adverse reactions	Exact identifier application applno (ANDA): 062447 application number: ANDA062447
erythromycin	ERYTHROMYCIN	A-S Medication Solutions	1df12239-6957-4b2c-9e65-e2154eafddd0	2023-02-04	Adverse reactions	Exact identifier application applno (ANDA): 062447 application number: ANDA062447 ndc (product): 50090-1958

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
63937KV33D	ERYTHROMYCIN	114-07-8	ERYTHROMYCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310149	erythromycin 0.5 % (5 MG/GM) Ophthalmic Ointment	PSN	1df12239-6957-4b2c-9e65-e2154eafddd0	15
310149	erythromycin 0.005 MG/MG Ophthalmic Ointment	SCD	1df12239-6957-4b2c-9e65-e2154eafddd0	15
310149	erythromycin 0.5 % Ophthalmic Ointment	SY	1df12239-6957-4b2c-9e65-e2154eafddd0	15
310149	erythromycin 5 MG per GM Ophthalmic Ointment	SY	1df12239-6957-4b2c-9e65-e2154eafddd0	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1958-0	50090195800	1 TUBE in 1 CARTON (50090-1958-0) / 3.5 g in 1 TUBE	1 tube	2015-08-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ERYTHROMYCIN OPHTHALMIC OINTMENT USP STERILE RX ONLY	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	15