NDC codes

FDA NDC Directory
Product NDC (as listed)49252-008Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49252-0008Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
49252-008-10492520008104925200081030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-008-10)Marketed from Dec 5, 2015
49252-008-11492520008114925200081160 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-008-11)Marketed from Dec 5, 2015
49252-008-12492520008124925200081290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-008-12)Marketed from Dec 5, 2015
49252-008-1849252000818492520008181000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-008-18)Marketed from Dec 5, 2015
49252-008-574925200085749252000857100 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (49252-008-57)Marketed from Dec 5, 2015

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
duloxetine
Generic name (nonproprietary)
duloxetine
Active ingredients
Duloxetine hydrochloride — 30 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Inventia Healthcare Limited.NDC labeler code 49252
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202336
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 49252-008_3fb45d3e-3fbc-8814-e063-6294a90a4a70SPL ID 3fb45d3e-3fbc-8814-e063-6294a90a4a70SPL set ID eab90059-ea1c-46c1-884d-c15e7c562a01RxCUI 596926, 596930, 596934UNII 9044SC542WUPC 0349252007574, 0349252009103, 0349252008106, 0349252008571, 0349252009578

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N449252000810 followed by a unit qualifier and the quantity

Package 49252-0008-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

Duloxetine is indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adults and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults Duloxetine delayed-release capsules USP is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: Major depressive disorder (MDD) in adults ( 1 ) Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older ( 1 ) Diabetic peripheral neuropathic pain (DPNP) in adults ( 1 ) Fibromyal…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49252-008

What is NDC 49252-008?
49252-008 is the product NDC for duloxetine, Duloxetine hydrochloride 30 mg/1 capsule, delayed release, listed with the FDA by Inventia Healthcare Limited.. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
duloxetine.
What is the active ingredient?
Duloxetine hydrochloride.
Who is the labeler?
Inventia Healthcare Limited., NDC labeler code 49252. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for duloxetine?
140 other product NDCs are listed under this name. See all duloxetine NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other duloxetine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralANI Pharmaceuticals, Inc.70954-86070954-0860-30
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralANI Pharmaceuticals, Inc.70954-86170954-0861-20
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralANI Pharmaceuticals, Inc.70954-86470954-0864-20
DuloxetineDuloxetine hydrochloride 120 mg/1Capsule, Delayed releaseOralAlmatica Pharma LLC52427-79152427-0791-30
DuloxetineDuloxetine hydrochloride 80 mg/1Capsule, Delayed releaseOralAlmatica Pharma LLC52427-82152427-0821-30
DuloxetineDuloxetine hydrochloride 90 mg/1Capsule, Delayed releaseOralAlmatica Pharma LLC52427-91352427-0913-30
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-412868788-4128-0368788-4128-0668788-4128-09
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralCoupler LLC67046-159867046-1598-03
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralCoupler LLC67046-158567046-1585-03
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralPreferred Phamaceuticals Inc.68788-402568788-4025-0368788-4025-0668788-4025-09

All 141 duloxetine NDCs

Other NDCs under ANDA 202336

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 202336
ProductStrengthForm · routeLabelerProduct NDC
duloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralInventia Healthcare Limited.49252-007
duloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralInventia Healthcare Limited.49252-009
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralANI Pharmaceuticals, Inc.70954-860
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralANI Pharmaceuticals, Inc.70954-861
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralANI Pharmaceuticals, Inc.70954-864

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