Erythromycin

Product NDC: 63187-608
11-digit product format: 631870608
Labeler code: 63187
Product ID: 63187-608_bb8e6b6b-70fd-48b7-b43d-23180531dc9f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Erythromycin
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: Proficient Rx LP
Application: ANDA064067
Marketing category: ANDA
Marketing start: 1994-07-29
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 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
A064067-001	ERYTHROMYCIN	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064067-001	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.

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	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`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	A064067-001	AT	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Erythromycin	ERYTHROMYCIN	Sportpharm LLC	790d3e3e-df69-45f7-97d5-da65faa46556	2026-07-21	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067
Erythromycin	ERYTHROMYCIN	Cardinal Health 107, LLC	ba4f06c3-ebce-4896-a5cc-59bb5c2cb4e5	2026-04-27	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067
Erythromycin	ERYTHROMYCIN	Preferred Pharmaceuticals, Inc.	ee3d806e-65ce-42e1-b170-7b35bcb7b06a	2026-04-10	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067
ERYTHROMYCIN	ERYTHROMYCIN	Direct Rx	9ac4dcd2-8cac-404d-b651-da74062d30ed	2026-03-17	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067
Erythromycin	ERYTHROMYCIN	REMEDYREPACK INC.	c49ad63b-c2fd-4535-bec0-6415c93cf847	2026-01-09	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067
Erythromycin	ERYTHROMYCIN	A-S Medication Solutions	2be16639-b153-407b-b43d-3a2bcf66151e	2025-12-03	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067
Erythromycin	ERYTHROMYCIN	Bausch & Lomb Incorporated	061ddd20-94a6-4e3c-ba84-1ebd8529eea6	2025-04-22	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067
Erythromycin	ERYTHROMYCIN	NuCare Pharmaceuticals,Inc.	5568ade8-bdc2-1a32-e054-00144ff8d46c	2024-08-14	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067
Erythromycin	ERYTHROMYCIN	NuCare Pharmaceuticals,Inc.	6296e2ed-334c-b9af-e053-2991aa0aae0c	2024-06-06	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067
Erythromycin	ERYTHROMYCIN	Proficient Rx LP	5101bf55-cacf-42bf-8dd1-2a29e80ca6f1	2022-07-01	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067 ndc (product): 63187-608
Erythromycin	ERYTHROMYCIN	Asclemed USA, Inc.	7810e881-5130-4a94-b2e0-9f63f8a7a504	2021-11-30	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067

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
5101bf55-cacf-42bf-8dd1-2a29e80ca6f1	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63187-608-35	Erythromycin	1 in 1 CARTON	OINTMENT	1		5
63187-608-35	Erythromycin	3.5 g in 1 TUBE	OINTMENT	3.5		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-608-35	GM - Gram	63187-608	41226641-58ea-4f30-92c8-ef88b2523587	1	2016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-608	ERYTHROMYCIN OINTMENT [PROFICIENT RX LP]	5	Current NDC, Legacy NDC, 2 package rows	20220716_5101bf55-cacf-42bf-8dd1-2a29e80ca6f1.zip

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	5101bf55-cacf-42bf-8dd1-2a29e80ca6f1	5
310149	erythromycin 0.005 MG/MG Ophthalmic Ointment	SCD	5101bf55-cacf-42bf-8dd1-2a29e80ca6f1	5
310149	erythromycin 0.5 % Ophthalmic Ointment	SY	5101bf55-cacf-42bf-8dd1-2a29e80ca6f1	5
310149	erythromycin 5 MG per GM Ophthalmic Ointment	SY	5101bf55-cacf-42bf-8dd1-2a29e80ca6f1	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-608-35	63187060835	1 TUBE in 1 CARTON (63187-608-35) / 3.5 g in 1 TUBE	1 tube	2018-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Erythromycin Ophthalmic Ointment USP, 0.5% (Sterile)	Proficient Rx LP	2022-07-01	HUMAN PRESCRIPTION DRUG LABEL	5