erythromycin

Product NDC: 45802-038
11-digit product format: 458020038
Labeler code: 45802
Product ID: 45802-038_81c83ddb-5432-484c-8a60-e51677a62c6b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: erythromycin
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA063038
Marketing category: ANDA
Marketing start: 2011-12-19
Substance: ERYTHROMYCIN
Active strength: 20 mg/mL
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 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
A063038-001	ERYTHROMYCIN	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A063038-001	AT

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063038-001	ERYTHROMYCIN	2%	SOLUTION / TOPICAL	AT	RS	1991-01-11	`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	A063038-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063038-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063038-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063038-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063038-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063038-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063038-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063038-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063038-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063038-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063038-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063038-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063038-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063038-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063038-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063038-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063038-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063038-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063038-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063038-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063038-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063038-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063038-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063038-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063038-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063038-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063038-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063038-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063038-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063038-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063038-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063038-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063038-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063038-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063038-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063038-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063038-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063038-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063038-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063038-001	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	20 mg/mL

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
318202	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
40edf1bd-42bb-4662-aff6-01fcc133c05d	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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45802-038-46	erythromycin	60 mL in 1 BOTTLE	SOLUTION	60		11
45802-038-46	erythromycin	1 in 1 CARTON	SOLUTION	1		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-038-46	ML - Milliliter	45802-038	5b48f6c5-4aa6-4d48-af40-40e3bc0be0ed	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ERYTHROMYCIN	ACTIVE INGREDIENT	63937KV33D	ERYTHROMYCIN SOLUTION [PERRIGO NEW YORK INC]	4
ERYTHROMYCIN	ACTIVE MOIETY	63937KV33D	ERYTHROMYCIN SOLUTION [PERRIGO NEW YORK INC]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ERYTHROMYCIN SOLUTION [PERRIGO NEW YORK INC]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ERYTHROMYCIN SOLUTION [PERRIGO NEW YORK INC]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ERYTHROMYCIN SOLUTION [PERRIGO NEW YORK INC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-038	ERYTHROMYCIN SOLUTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]	10	Current NDC, Legacy NDC, 2 package rows	20220828_40edf1bd-42bb-4662-aff6-01fcc133c05d.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	Bryant Ranch Prepack	00c4f27e-59e2-4173-99b1-59dd295e83de	2024-10-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063038 application number: ANDA063038
erythromycin	ERYTHROMYCIN	NuCare Pharmaceuticals,Inc.	8349b4ec-3ca6-bdb6-e053-2a91aa0a8b63	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063038 application number: ANDA063038
erythromycin	ERYTHROMYCIN	Padagis Israel Pharmaceuticals Ltd	40edf1bd-42bb-4662-aff6-01fcc133c05d	2022-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063038 application number: ANDA063038 ndc (product): 45802-038

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
318202	erythromycin 2 % Topical Solution	PSN	00c4f27e-59e2-4173-99b1-59dd295e83de	101
318202	erythromycin 20 MG/ML Topical Solution	SCD	00c4f27e-59e2-4173-99b1-59dd295e83de	101
318202	erythromycin 2 % Topical Solution	SY	00c4f27e-59e2-4173-99b1-59dd295e83de	101
318202	erythromycin 2 % Topical Solution	PSN	40edf1bd-42bb-4662-aff6-01fcc133c05d	11
318202	erythromycin 20 MG/ML Topical Solution	SCD	40edf1bd-42bb-4662-aff6-01fcc133c05d	11
318202	erythromycin 2 % Topical Solution	SY	40edf1bd-42bb-4662-aff6-01fcc133c05d	11
318202	erythromycin 2 % Topical Solution	PSN	8349b4ec-3ca6-bdb6-e053-2a91aa0a8b63	4
318202	erythromycin 20 MG/ML Topical Solution	SCD	8349b4ec-3ca6-bdb6-e053-2a91aa0a8b63	4
318202	erythromycin 2 % Topical Solution	SY	8349b4ec-3ca6-bdb6-e053-2a91aa0a8b63	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-038-46	45802003846	1 BOTTLE in 1 CARTON (45802-038-46) / 60 mL in 1 BOTTLE	1 bottle	2011-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Erythromycin Topical Solution USP, 2%	Bryant Ranch Prepack	2024-10-11	HUMAN PRESCRIPTION DRUG LABEL	101
Erythromycin Topical Solution USP, 2%	NuCare Pharmaceuticals,Inc.	2024-06-14	HUMAN PRESCRIPTION DRUG LABEL	4
Erythromycin Topical Solution USP, 2%	Padagis Israel Pharmaceuticals Ltd	2022-08-27	HUMAN PRESCRIPTION DRUG LABEL	11