Home NDC 52959-892 Cymbalta
Product NDC 52959-892
11-digit product format 529590892
Labeler code 52959
Product ID 52959-892_908e6b8e-0116-4024-bcb4-4f27938301a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Duloxetine hydrochloride
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler H.J. Harkins Company, Inc.
Application NDA021427
Marketing category NDA
Marketing start 2010-01-15
Marketing end 0000-00-00
Substance DULOXETINE HYDROCHLORIDE
Active strength 60 mg/1
Pharmacologic classes Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52959-892-30 Cymbalta 30 in 1 BOTTLE CAPSULE, DELAYED RELEASE 30 1 52959-892-60 Cymbalta 60 in 1 BOTTLE CAPSULE, DELAYED RELEASE 60 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Duloxetine hydrochloride ACTIVE INGREDIENT 9044SC542W CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 1 Duloxetine ACTIVE MOIETY O5TNM5N07U CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 1 Gelatin INACTIVE INGREDIENT 2G86QN327L CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 1 HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S) INACTIVE INGREDIENT 24P2YXD2PW CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 1 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 1 Sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 1 Sucrose INACTIVE INGREDIENT C151H8M554 CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 1 Talc INACTIVE INGREDIENT 7SEV7J4R1U CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 1 Titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 1 Triethyl citrate INACTIVE INGREDIENT 8Z96QXD6UM CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-892 CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 1 Legacy NDC, 2 package rows 20111212_059d730b-4294-47e1-8399-4cb8c468cee8.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 52959-892-30 52959089230 30 in 1 BOTTLE Historical 52959-892-60 52959089260 60 in 1 BOTTLE Historical