Erythromycin

Product NDC: 68788-9328
11-digit product format: 687889328
Labeler code: 68788
Product ID: 68788-9328_b425ca64-ac45-4435-b700-2cad6f9d50f8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Erythromycin
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA064067
Marketing category: ANDA
Marketing start: 2015-04-02
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: 2027-12-31
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.

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	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	RS	1994-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064067-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1994-07-29	`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	A064067-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064067-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064067-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064067-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064067-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064067-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064067-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064067-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064067-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064067-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064067-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064067-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064067-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064067-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064067-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064067-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064067-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064067-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064067-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064067-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064067-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064067-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064067-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064067-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064067-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064067-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064067-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064067-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064067-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064067-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064067-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064067-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064067-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064067-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064067-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064067-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064067-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064067-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064067-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064067-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Erythromycin
Listing expiration: 2027-12-31

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
ee3d806e-65ce-42e1-b170-7b35bcb7b06a	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
68788-9328-3	Erythromycin	1 in 1 CARTON	OINTMENT	1		12
68788-9328-3	Erythromycin	3.5 g in 1 TUBE	OINTMENT	3.5		12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ERYTHROMYCIN	ACTIVE INGREDIENT	63937KV33D	ERYTHROMYCIN OINTMENT [PREFERRED PHARMACEUTICALS, INC.]	1
ERYTHROMYCIN	ACTIVE MOIETY	63937KV33D	ERYTHROMYCIN OINTMENT [PREFERRED PHARMACEUTICALS, INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	ERYTHROMYCIN OINTMENT [PREFERRED PHARMACEUTICALS, INC.]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	ERYTHROMYCIN OINTMENT [PREFERRED PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-9328	ERYTHROMYCIN OINTMENT [PREFERRED PHARMACEUTICALS, INC.]	11	Current NDC, Legacy NDC, 2 package rows	20250409_ee3d806e-65ce-42e1-b170-7b35bcb7b06a.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 · 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 ndc (product): 68788-9328
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
Erythromycin	ERYTHROMYCIN	Asclemed USA, Inc.	7810e881-5130-4a94-b2e0-9f63f8a7a504	2021-11-30	Adverse reactions	Exact identifier application applno (ANDA): 064067 application number: ANDA064067

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	ee3d806e-65ce-42e1-b170-7b35bcb7b06a	12
310149	erythromycin 0.005 MG/MG Ophthalmic Ointment	SCD	ee3d806e-65ce-42e1-b170-7b35bcb7b06a	12
310149	erythromycin 0.5 % Ophthalmic Ointment	SY	ee3d806e-65ce-42e1-b170-7b35bcb7b06a	12
310149	erythromycin 5 MG per GM Ophthalmic Ointment	SY	ee3d806e-65ce-42e1-b170-7b35bcb7b06a	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-9328-3	68788932803	1 TUBE in 1 CARTON (68788-9328-3) / 3.5 g in 1 TUBE	1 tube	2015-04-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Erythromycin Ophthalmic Ointment USP 0.5% (Sterile) Rx only	Preferred Pharmaceuticals, Inc.	2026-04-10	HUMAN PRESCRIPTION DRUG LABEL	12