What is NDC 62135-892?

62135-892 is the product NDC for Generlac (lactulose), Lactulose 10 g/15mL solution, listed with the FDA by Chartwell RX, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

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 Generlac?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Generlac NDC 62135-892 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-892Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0892Add 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 NDC	11-digit (billing)	Package	Copy
62135-892-47	62135089247	473 mL in 1 BOTTLE (62135-892-47)Marketed from Jul 10, 2024
62135-892-94	62135089294	946 mL in 1 BOTTLE (62135-892-94)Marketed from Jul 10, 2024

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): Generlac
Generic name (nonproprietary): lactulose
Active ingredients: Lactulose — 10 g/15mL
Dosage form: Solution
Route: Oral, Rectal
Labeler: Chartwell RX, LLCNDC labeler code 62135
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074603
Marketing start: Oct 31, 1996
Listing expires: Dec 31, 2026
Other FDA classes: Acidifying Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 62135-892_1d600b06-58c7-b83e-e063-6294a90a86f9SPL ID 1d600b06-58c7-b83e-e063-6294a90a86f9SPL set ID 35207edd-a5fe-4369-a079-7a8b0d2f2e91RxCUI 391937, 544455UNII 9U7D5QH5AEUPC 0362135892470
Pharmacologic class: Osmotic Laxative

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N462135089247 followed by a unit qualifier and the quantity

Package 62135-0892-47. 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 Jul 16, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by an improvement in the patients' mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients' protein tolerance is also frequently observed with lactulose solution therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose solution has been g…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62135-892

What is NDC 62135-892?: 62135-892 is the product NDC for Generlac (lactulose), Lactulose 10 g/15mL 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?: Generlac (Lactulose).
What is the active ingredient?: Lactulose.
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 Generlac?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Generlac (Lactulose) NDC 62135-892