NDC codes

FDA NDC Directory
Product NDC (as listed)27241-164Labeler and product segments. Claims need a package NDC.
Product NDC at billing width27241-0164Add 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
27241-164-30272410164302724101643030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-164-30)Marketed from Mar 25, 2019

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 — 40 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Ajanta Pharma USA Inc.NDC labeler code 27241
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208706
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 27241-164_ae1a8c02-c1fc-474a-9411-cebecd99e339SPL ID ae1a8c02-c1fc-474a-9411-cebecd99e339SPL set ID 2dde979d-b6f8-41d1-96fb-325c75ea3a74RxCUI 596926, 596930, 596934, 616402UNII 9044SC542WUPC 0327241164309, 0327241099038, 0327241097065, 0327241098031

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

N427241016430 followed by a unit qualifier and the quantity

Package 27241-0164-30. 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 and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults Duloxetine delayed-release capsules are 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 27241-164

What is NDC 27241-164?
27241-164 is the product NDC for Duloxetine, Duloxetine hydrochloride 40 mg/1 capsule, delayed release, listed with the FDA by Ajanta Pharma USA Inc.. 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?
Ajanta Pharma USA Inc., NDC labeler code 27241. 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?
145 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 120 mg/1Capsule, Delayed releaseOralAlmatica Pharma LLC52427-79152427-0791-30
DuloxetineDuloxetine hydrochloride 90 mg/1Capsule, Delayed releaseOralAlmatica Pharma LLC52427-91352427-0913-30
DuloxetineDuloxetine hydrochloride 80 mg/1Capsule, Delayed releaseOralAlmatica Pharma LLC52427-82152427-0821-30
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 60 mg/1Capsule, Delayed releaseOralSt Mary's Medical Park Pharmacy60760-46260760-0462-6060760-0462-90
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralPreferred Phamaceuticals Inc.68788-402568788-4025-0368788-4025-0668788-4025-09
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralPreferred Phamaceuticals Inc.68788-402668788-4026-0368788-4026-0668788-4026-09
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralCoupler LLC67046-158567046-1585-03
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-444070518-4440-0070518-4440-0170518-4440-03+1 more

All 146 Duloxetine NDCs

Other NDCs under ANDA 208706

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

FDA NDC Directory listings under ANDA 208706
ProductStrengthForm · routeLabelerProduct NDC
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralAjanta Pharma USA Inc.27241-097
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralAjanta Pharma USA Inc.27241-098
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralAjanta Pharma USA Inc.27241-099
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-5940
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-6893
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-6899
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-6900
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7812
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralNorthwind Health Company, LLC51655-237
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralSt. Mary's Medical Park Pharmacy60760-461
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralSt. Mary's Medical Park Pharmacy60760-462
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralSt. Mary's Medical Park Pharmacy60760-759
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralCoupler LLC67046-1451
DuloxetineDuloxetine hydrochloride 40 mg/1Capsule, Delayed releaseOralBluePoint Laboratories68001-570
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralBluePoint Laboratories68001-594
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralBluePoint Laboratories68001-595
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralBluePoint Laboratories68001-596
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-3519
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals, Inc.68071-3766
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals, Inc.68071-3979

Showing 20 of 39.

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