Erythromycin

Product NDC: 63629-8653
11-digit product format: 636298653
Labeler code: 63629
Product ID: 63629-8653_18c0dd25-f6be-49f0-b83e-ee20d3bb5117
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Erythromycin
Dosage form: GEL
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: ANDA063211
Marketing category: ANDA
Marketing start: 2008-06-12
Substance: ERYTHROMYCIN
Active strength: 20 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 43.

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
A063211-001	ERYTHROMYCIN	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	RS	1993-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A063211-001	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 2 of 2 · 43 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
2022-09-29 23:25 UTC	2022-09	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT		1993-01-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A063211-001	ERYTHROMYCIN	2%	GEL / TOPICAL	AT	RS	1993-01-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A063211-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A063211-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A063211-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063211-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063211-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063211-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063211-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063211-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063211-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063211-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063211-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063211-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063211-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063211-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063211-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063211-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063211-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063211-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063211-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063211-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063211-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063211-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063211-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063211-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063211-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063211-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063211-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063211-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063211-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063211-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063211-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063211-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063211-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063211-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063211-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063211-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063211-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063211-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063211-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063211-001	AT	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

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/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
310152	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
939bccc7-b4a0-4a5c-a6f5-b12627ff8e9b	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
63629-8653-1	Erythromycin	1 in 1 CARTON	GEL	1		104
63629-8653-1	Erythromycin	60 g in 1 TUBE	GEL	60		104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8653-1	GM - Gram	63629-8653	46858270-5a09-4aac-a816-62643487aa64	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8653	ERYTHROMYCIN GEL [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 2 package rows	20240711_939bccc7-b4a0-4a5c-a6f5-b12627ff8e9b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Erythromycin	ERYTHROMYCIN	Bryant Ranch Prepack	10ad1391-32fc-40c0-96d0-675f3c91429f	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063211 application number: ANDA063211
Erythromycin	ERYTHROMYCIN	Bryant Ranch Prepack	b7d11564-c92d-4eed-bdd9-8fc355e7dfc7	2023-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063211 application number: ANDA063211
Erythromycin	ERYTHROMYCIN	Bryant Ranch Prepack	939bccc7-b4a0-4a5c-a6f5-b12627ff8e9b	2023-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063211 application number: ANDA063211 ndc (product): 63629-8653
Erythromycin	ERYTHROMYCIN	Padagis Israel Pharmaceuticals Ltd	dd64459e-c88f-4ca8-b63b-fb96377a3921	2023-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063211 application number: ANDA063211

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
310152	erythromycin 2 % Topical Gel	PSN	939bccc7-b4a0-4a5c-a6f5-b12627ff8e9b	104
310152	erythromycin 0.02 MG/MG Topical Gel	SCD	939bccc7-b4a0-4a5c-a6f5-b12627ff8e9b	104
310152	erythromycin 2 % Topical Gel	SY	939bccc7-b4a0-4a5c-a6f5-b12627ff8e9b	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8653-1	63629865301	1 TUBE in 1 CARTON (63629-8653-1) / 60 g in 1 TUBE	1 tube	2008-06-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Erythromycin Topical Gel USP, 2%	Bryant Ranch Prepack	2023-07-17	HUMAN PRESCRIPTION DRUG LABEL	104