NDC codes

FDA NDC Directory
Product NDC (as listed)0615-7698Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00615-7698Add 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
0615-7698-39006157698390061576983930 TABLET in 1 BLISTER PACK (0615-7698-39)Marketed from Nov 18, 2011

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)
Metoclopramide
Generic name (nonproprietary)
metoclopramide
Active ingredients
Metoclopramide hydrochloride — 5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 072801
Marketing start
Listing expires
Other FDA classes
Dopamine D2 Antagonists (Mechanism)
Identifiers
Product ID 0615-7698_c8471d07-1fca-4135-9b0e-cc9f5e037a18SPL ID c8471d07-1fca-4135-9b0e-cc9f5e037a18SPL set ID 4ab8ddab-8226-4b5a-8774-308ed49d6bc4RxCUI 311666, 311668UNII W1792A2RVD
Pharmacologic class
Dopamine-2 Receptor Antagonist

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

N400615769839 followed by a unit qualifier and the quantity

Package 00615-7698-39. 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)

Metoclopramide tablets are indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Limitations of Use: Metoclopramide tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see Use in Specific Populations ( 8.4 )]. Metoclopramide tablets are indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to convent…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-7698

What is NDC 0615-7698?
0615-7698 is the product NDC for Metoclopramide, Metoclopramide hydrochloride 5 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Metoclopramide.
What is the active ingredient?
Metoclopramide hydrochloride.
Who is the labeler?
NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Metoclopramide?
71 other product NDCs are listed under this name. See all Metoclopramide 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 Metoclopramide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MetoclopramideMetoclopramide hydrochloride 5 mg/mLInjection, SolutionIntramuscular, IntravenousBaxter Healthcare Corporation36000-36636000-0366-25
MetoclopramideMetoclopramide hydrochloride 5 mg/1TabletOralCoupler LLC67046-018667046-0186-03
MetoclopramideMetoclopramide hydrochloride 10 mg/1TabletOralCoupler LLC67046-058167046-0581-03
Metoclopramidemetoclopramide hydrochlorideMetoclopramide hydrochloride 5 mg/mLInjectionIntramuscular, IntravenousHenry Schein, Inc.0404-977100404-9771-02
MetoclopramideMetoclopramide hydrochloride 5 mg/1TabletOralSafecor Health LLC48433-06648433-0066-20
MetoclopramideMetoclopramide hydrochloride 10 mg/1TabletOralSafecor Health LLC48433-06748433-0067-20
MetoclopramideMetoclopramide hydrochloride 10 mg/1TabletOralREMEDYREPACK INC.70518-454170518-4541-00
MetoclopramideMetoclopramide hydrochloride 5 mg/mLInjection, SolutionIntramuscular, IntravenousCardinal Health 107, LLC55154-783255154-7832-05
MetoclopramideMetoclopramide hydrochloride 5 mg/1TabletOralScieGen Pharmaceuticals, Inc.50228-23250228-0232-0150228-0232-05
MetoclopramideMetoclopramide hydrochloride 10 mg/1TabletOralScieGen Pharmaceuticals, Inc.50228-23350228-0233-0150228-0233-0550228-0233-10

All 72 Metoclopramide NDCs

Other NDCs under ANDA 072801

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

FDA NDC Directory listings under ANDA 072801
ProductStrengthForm · routeLabelerProduct NDC
MetoclopramideMetoclopramide hydrochloride 5 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-2204
MetoclopramideMetoclopramide hydrochloride 5 mg/1TabletOralSafecor Health LLC48433-066
MetoclopramideMetoclopramide hydrochloride 5 mg/1TabletOralMylan Institutional Inc.51079-886
MetoclopramideMetoclopramide hydrochloride 5 mg/1TabletOralCardinal Health 107, LLC55154-4383
MetoclopramideMetoclopramide hydrochloride 5 mg/1TabletOralAmerican Health Packaging60687-620
MetoclopramideMetoclopramide hydrochloride 5 mg/1TabletOralNuCare Pharmaceuticals, Inc.66267-841
MetoclopramideMetoclopramide hydrochloride 5 mg/1TabletOralCoupler LLC67046-0186
MetoclopramideMetoclopramide hydrochloride 5 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3923
MetoclopramideMetoclopramide hydrochloride 5 mg/1TabletOralBryant Ranch Prepack71335-1259

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