NDC codes

FDA NDC Directory
Product NDC (as listed)62135-526Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0526Add 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
62135-526-2462135052624621350526242 TRAY in 1 BOX (62135-526-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-526-10)Marketed from Oct 14, 2024
62135-526-476213505264762135052647473 mL in 1 BOTTLE (62135-526-47)Marketed from Mar 21, 2023

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)
metoclopramide hydrochloride
Generic name (nonproprietary)
metoclopramide hydrochloride
Active ingredients
Metoclopramide hydrochloride — 5 mg/5mL
Dosage form
Solution
Route
Oral
Labeler
Chartwell RX, LLCNDC labeler code 62135
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 073680
Marketing start
Listing expires
Other FDA classes
Dopamine D2 Antagonists (Mechanism)
Identifiers
Product ID 62135-526_49dc78f2-e942-afb5-e063-6394a90a20d5SPL ID 49dc78f2-e942-afb5-e063-6394a90a20d5SPL set ID dc364325-dd39-4259-a348-3760eccdca4bRxCUI 104884UNII W1792A2RVDUPC 0362135526474
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

N462135052624 followed by a unit qualifier and the quantity

Package 62135-0526-24. 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 The use of Metoclopramide Oral Solution is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux Metoclopramide Oral Solution is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather tha…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62135-526

What is NDC 62135-526?
62135-526 is the product NDC for metoclopramide hydrochloride, Metoclopramide hydrochloride 5 mg/5mL solution, listed with the FDA by Chartwell RX, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
metoclopramide hydrochloride.
What is the active ingredient?
Metoclopramide hydrochloride.
Who is the labeler?
Chartwell RX, LLC, NDC labeler code 62135. 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 hydrochloride?
3 other product NDCs are listed under this name. See all metoclopramide hydrochloride 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 hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
METOCLOPRAMIDE hydrochlorideMetoclopramide hydrochloride 10 mg/1Tablet, Orally disintegratingOralLupin Pharmaceuticals,Inc.43386-58043386-0580-31
METOCLOPRAMIDE hydrochlorideMetoclopramide hydrochloride 5 mg/1Tablet, Orally disintegratingOralLupin Pharmaceuticals,Inc.43386-58143386-0581-31
metoclopramide hydrochlorideMetoclopramide hydrochloride 5 mg/5mLSolutionOralChartwell Governmental & Specialty RX, LLC.68999-52668999-0526-24

Other NDCs under ANDA 073680

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

FDA NDC Directory listings under ANDA 073680
ProductStrengthForm · routeLabelerProduct NDC
metoclopramide hydrochlorideMetoclopramide hydrochloride 5 mg/5mLSolutionOralChartwell Governmental & Specialty RX, LLC.68999-526

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