NDC codes

FDA NDC Directory
Product NDC (as listed)70247-012Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70247-0012Add 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
70247-012-06702470012067024700120660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70247-012-06)Marketed from May 8, 2018

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 — 20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Qingdao BAHEAL Pharmaceutical Co., Ltd.NDC labeler code 70247
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210599
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 70247-012_435c56f7-5995-3906-e063-6394a90af073SPL ID 435c56f7-5995-3906-e063-6394a90af073SPL set ID e428429e-e1ea-40e1-870f-134533dc3aa1RxCUI 596926, 596930, 596934UNII 9044SC542WUPC 0370247013034, 0370247014031, 0370247014062, 0370247012068, 0370247014505, 0370247013096, 0370247013102

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

N470247001206 followed by a unit qualifier and the quantity

Package 70247-0012-06. 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 delayed-release capsules are 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 • Chronic Musculoskeletal Pain in adults. Additional pediatric use information is approved for Eli Lilly and Company, Inc.'s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70247-012

What is NDC 70247-012?
70247-012 is the product NDC for duloxetine, Duloxetine hydrochloride 20 mg/1 capsule, delayed release, listed with the FDA by Qingdao BAHEAL Pharmaceutical Co., Ltd.. It has 1 package NDC, 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?
Qingdao BAHEAL Pharmaceutical Co., Ltd., NDC labeler code 70247. 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 210599

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

FDA NDC Directory listings under ANDA 210599
ProductStrengthForm · routeLabelerProduct NDC
duloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralQingdao BAHEAL Pharmaceutical Co., Ltd.70247-013
duloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralQingdao BAHEAL Pharmaceutical Co., Ltd.70247-014

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