NDC codes

FDA NDC Directory
Product NDC (as listed)0527-3236Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00527-3236Add 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
0527-3236-370052732363700527323637100 TABLET in 1 BOTTLE (0527-3236-37)Marketed from May 20, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Levorphanol Tartrate
Generic name (nonproprietary)
levorphanol tartrate
Active ingredients
Levorphanol tartrate — 2 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Lannett Company, Inc.NDC labeler code 0527
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213479
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 0527-3236_a0edf042-6bef-434f-bd7e-ca4a899c1841SPL ID a0edf042-6bef-434f-bd7e-ca4a899c1841SPL set ID a50debe1-90b3-4931-9ec0-67e88dd21b04RxCUI 197873, 2058845UNII 04WQU6T9QIUPC 0305273236379, 0305273237376
Pharmacologic class
Opioid Agonist

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

N400527323637 followed by a unit qualifier and the quantity

Package 00527-3236-37. 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)

INDICATIONS AND USAGE Levorphanol tartrate tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS ] , reserve opioid analgesics, includinglevorphanol, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0527-3236

What is NDC 0527-3236?
0527-3236 is the product NDC for Levorphanol Tartrate, Levorphanol tartrate 2 mg/1 tablet, listed with the FDA by Lannett Company, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Levorphanol Tartrate.
What is the active ingredient?
Levorphanol tartrate.
Who is the labeler?
Lannett Company, Inc., NDC labeler code 0527. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Levorphanol Tartrate?
9 other product NDCs are listed under this name. See all Levorphanol Tartrate 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 Levorphanol Tartrate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Levorphanol TartrateLevorphanol tartrate 2 mg/1TabletOralACERTIS PHARMACEUTICALS, LLC72989-41772989-0417-10
Levorphanol TartrateLevorphanol tartrate 3 mg/1TabletOralSun Pharmaceutical Industries, Inc.57664-05857664-0058-88
Levorphanol TartrateLevorphanol tartrate 2 mg/1TabletOralSun Pharmaceutical Industries, Inc.57664-76257664-0762-88
Levorphanol TartrateLevorphanol tartrate 2 mg/1TabletOralVirtus Pharmaceuticals, LLC69543-41769543-0417-10
Levorphanol TartrateLevorphanol tartrate 2 mg/1TabletOralBryant Ranch Prepack72162-230972162-2309-01
Levorphanol TartrateLevorphanol tartrate 3 mg/1TabletOralLannett Company, Inc.0527-323700527-3237-37
Levorphanol TartrateLevorphanol tartrate 2 mg/1TabletOralSpecGx LLC0406-222400406-2224-01
Levorphanol TartrateLevorphanol tartrate 2 mg/1TabletOralBryant Ranch Prepack63629-209363629-2093-01
Levorphanol TartrateLevorphanol tartrate 2 mg/1TabletOralHikma Pharmaceuticals USA Inc.0054-043800054-0438-25

Other NDCs under ANDA 213479

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

FDA NDC Directory listings under ANDA 213479
ProductStrengthForm · routeLabelerProduct NDC
Levorphanol TartrateLevorphanol tartrate 3 mg/1TabletOralLannett Company, Inc.0527-3237
Levorphanol TartrateLevorphanol tartrate 2 mg/1TabletOralBryant Ranch Prepack63629-2093

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