HADLIMA

Product NDC: 50090-6707
11-digit product format: 500906707
Labeler code: 50090
Product ID: 50090-6707_6ac2e906-b32e-4c8e-909f-ff26b987d0c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: adalimumab-bwwd
Dosage form: SOLUTION
Route: SUBCUTANEOUS
Labeler: A-S Medication Solutions
Application: BLA761059
Marketing category: BLA
Marketing start: 2023-07-01
Substance: ADALIMUMAB
Active strength: 40 mg/.4mL
Pharmacologic classes: Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 50090-6707_6ac2e906-b32e-4c8e-909f-ff26b987d0c3
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: HADLIMA
Generic name: adalimumab-bwwd
Dosage form: SOLUTION
Route: SUBCUTANEOUS
Marketing start: 2023-07-01
Marketing category: BLA
Application number: BLA761059
Pharmacologic classes: Antibodies; Monoclonal [CS]; Tumor Necrosis Factor Blocker [EPC]; Tumor Necrosis Factor Receptor Blocking Activity [MoA]
Listing expiration: 2027-12-31

Ingredient	Strength
ADALIMUMAB	40 mg/.4mL

UNII	Preferred term	Registry number	Matched term
FYS6T7F842	ADALIMUMAB	331731-18-1	ADALIMUMAB

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-6707-0	50090670700	2 SYRINGE in 1 CARTON (50090-6707-0) / .4 mL in 1 SYRINGE	2 syringe	2023-09-27	No	No	Current

Title	Manufacturer	Effective date	Type	Version
HADLIMA	A-S Medication Solutions	2026-05-14	HUMAN PRESCRIPTION DRUG LABEL	3