daptomycin

Product NDC: 67457-813
11-digit product format: 674570813
Labeler code: 67457
Product ID: 67457-813_c32c2064-dd66-4c7f-a35b-c98048a4d3d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: daptomycin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Mylan Institutional LLC
Application: ANDA205037
Marketing category: ANDA
Marketing start: 2018-09-04
Substance: DAPTOMYCIN
Active strength: 500 mg/10mL
Pharmacologic classes: Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: daptomycin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DAPTOMYCIN	500 mg/10mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	NWQ5N31VKK
Rxcui	403920

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
45ca3ac7-6ee8-4e99-92a6-dc0b401e151a	Product name	1	20250724
223d8260-7a4e-4ebd-9635-845422d6a8ad	Product name	9	20240909
ca803a62-3799-476f-bbc6-024f77cb0320	Product name	4	20240207
cad85d83-8fb9-49f8-a5a6-a399af412964	Product name	1	20230922
8e59a5ed-f224-4156-b534-1ae4d0b6dfd7	Product name	1	20230721
ea2c89ab-e8f8-425f-9693-c923fa1e1703	Product name	1	20220929

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67457-813-50	daptomycin	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	10		9
67457-813-50	daptomycin	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67457-813-50	EA - Each	67457-813	cc55fe0e-d9f2-40b1-9020-a9ef03e8718f	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67457-813	DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]	7	Current NDC, Legacy NDC, 2 package rows	20220427_b7737862-e783-4af3-9521-ae00ed7a42aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
403920	DAPTOmycin 500 MG Injection	PSN	b7737862-e783-4af3-9521-ae00ed7a42aa	9
403920	daptomycin 500 MG Injection	SCD	b7737862-e783-4af3-9521-ae00ed7a42aa	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67457-813-50	67457081350	1 VIAL, SINGLE-DOSE in 1 CARTON (67457-813-50) / 10 mL in 1 VIAL, SINGLE-DOSE	2018-09-04	0000-00-00	No	No	Current