Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Novel Laboratories, Inc.
793518643
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Novel Laboratories, Inc.
Lupin Pharmaceuticals,Inc.
Novel Laboratories, Inc.
793518643
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocodone Bitartrate and Homatropine Methylbromide
Product Details
NDC Product Code
43386-118Application Number
ANDA091528Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 30, 2024HydrocodoneActive
Code: NO70W886KKClass: ACTIBQuantity: 5 mg in 1 1
Code: 68JRS2HC1CClass: ACTIBQuantity: 1.5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT