NDC codes

FDA NDC Directory
Product NDC (as listed)62135-556Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0556Add 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
62135-556-24621350556242 TRAY in 1 BOX (62135-556-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (62135-556-51)Marketed from May 31, 2024
62135-556-4762135055647473 mL in 1 BOTTLE (62135-556-47)Marketed from Oct 27, 2022

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)
Theophylline
Generic name (nonproprietary)
theophylline
Active ingredients
Theophylline anhydrous — 80 mg/15mL
Dosage form
Solution
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091156
Marketing start
Listing expires
Other FDA classes
Xanthines (Chemical structure)
Identifiers
Product ID 62135-556_4a2adbbe-acaa-a2bf-e063-6294a90a44c3SPL ID 4a2adbbe-acaa-a2bf-e063-6294a90a44c3SPL set ID 1b685384-5d96-46fa-b93b-e96538a2cfe7RxCUI 313306UNII 0I55128JYKUPC 0362135556471
Pharmacologic class
Methylxanthine

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

N462135055624 followed by a unit qualifier and the quantity

Package 62135-0556-24. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091156

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

FDA NDC Directory listings under ANDA 091156
ProductStrengthForm · routeLabelerProduct NDC
TheophyllineTheophylline anhydrous 80 mg/15mLSolutionOralChartwell Governmental & Specialty RX, LLC.68999-556

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