Prescription drug · ANDA

Theophylline NDC 72578-173

Theophylline anhydrous 300 mg/1 · Tablet, Extended release · Oral · Viona Pharmaceuticals Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)72578-173Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72578-0173Add 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
72578-173-0172578017301100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-173-01)Marketed from May 25, 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)
Theophylline
Generic name (nonproprietary)
theophylline
Active ingredients
Theophylline anhydrous — 300 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218063
Marketing start
Listing expires
Other FDA classes
Xanthines (Chemical structure)
Identifiers
Product ID 72578-173_1e5a0f45-86aa-498a-9cc3-9f7acc210ed6SPL ID 1e5a0f45-86aa-498a-9cc3-9f7acc210ed6SPL set ID abdfb9b9-9402-4761-9347-8eb1c4d86242RxCUI 314241, 317769UNII 0I55128JYK
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

N472578017301 followed by a unit qualifier and the quantity

Package 72578-0173-01. 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 extended-release tablets are 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 218063

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

FDA NDC Directory listings under ANDA 218063
ProductStrengthForm · routeLabelerProduct NDC
TheophyllineTheophylline anhydrous 300 mg/1Tablet, Extended releaseOralZydus Lifesciences Limited70771-1782
TheophyllineTheophylline anhydrous 450 mg/1Tablet, Extended releaseOralZydus Lifesciences Limited70771-1783
TheophyllineTheophylline anhydrous 450 mg/1Tablet, Extended releaseOralViona Pharmaceuticals Inc72578-174

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Theophylline NDC 72578-173 | Med-Code