Erythromycin Lactobionate

Product NDC: 66794-251
11-digit product format: 667940251
Labeler code: 66794
Product ID: 66794-251_593675b3-e44e-0b1e-e063-6294a90a3ee7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Erythromycin Lactobionate
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Piramal Critical Care Inc.
Application: ANDA216761
Marketing category: ANDA
Marketing start: 2026-08-13
Substance: ERYTHROMYCIN LACTOBIONATE
Active strength: 500 mg/1
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 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
A216761-001	ERYTHROMYCIN LACTOBIONATE	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2024-11-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216761-001	AP

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216761-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216761-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216761-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216761-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216761-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216761-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216761-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216761-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216761-001	AP	1	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216761-001	AP	1	`a50c72e98297…`

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 Lactobionate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ERYTHROMYCIN LACTOBIONATE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
33H58I7GLQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1668264	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
ee345752-0f0c-c69b-e053-2995a90a7dac	Available on FDA.report

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 Lactobionate	ERYTHROMYCIN LACTOBIONATE	Piramal Critical Care Inc.	ee345752-0f0c-c69b-e053-2995a90a7dac	2026-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216761 application number: ANDA216761 ndc (product): 66794-251
Erythromycin Lactobionate	ERYTHROMYCIN LACTOBIONATE	Armas Pharmaceuticals Inc.	ca65a48f-5fe6-4b31-8359-51dbc31f6d4e	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216761 application number: ANDA216761
erythromycin lactobionate	ERYTHROMYCIN LACTOBIONATE	Gland Pharma Limited	c6f9565b-6d9d-40e3-87f8-9f38ede9173a	2024-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216761 application number: ANDA216761

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
33H58I7GLQ	ERYTHROMYCIN LACTOBIONATE	3847-29-8	ERYTHROMYCIN LACTOBIONATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
66794-251-41	66794025141	10 VIAL in 1 CARTON (66794-251-41) / 500 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-251-02)	10 vial	2026-08-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Erythromycin Lactobionate	Piramal Critical Care Inc. \| Gland Pharma Limited	2026-08-16	HUMAN PRESCRIPTION DRUG LABEL	4