What is NDC 82638-106?

82638-106 is the product NDC for Theophylline, Theophylline anhydrous 450 mg/1 tablet, extended release, listed with the FDA by Harman Finochem Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Harman Finochem Limited, NDC labeler code 82638. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Theophylline?

40 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Theophylline NDC 82638-106 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)82638-106Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82638-0106Add 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
82638-106-02	8263801060282638010602	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (82638-106-02)Marketed from Jul 30, 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 — 450 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Harman Finochem LimitedNDC labeler code 82638
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214806
Marketing start: May 31, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Xanthines (Chemical structure)
Identifiers: Product ID 82638-106_171269d1-329b-8551-e063-6294a90aedd7SPL ID 171269d1-329b-8551-e063-6294a90aedd7SPL set ID 098db8bb-fa9a-4577-b7d9-86caaefc168aRxCUI 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

N482638010602 followed by a unit qualifier and the quantity

Package 82638-0106-02. 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 Apr 27, 2024.

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)

About NDC 82638-106

What is NDC 82638-106?: 82638-106 is the product NDC for Theophylline, Theophylline anhydrous 450 mg/1 tablet, extended release, listed with the FDA by Harman Finochem Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Theophylline.
What is the active ingredient?: Theophylline anhydrous.
Who is the labeler?: Harman Finochem Limited, NDC labeler code 82638. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Theophylline?: 40 other product NDCs are listed under this name. See all Theophylline 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 Theophylline NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Theophylline	Theophylline anhydrous 300 mg/1	Tablet, Extended releaseOral	Ajanta Pharma USA Inc.	27241-272	27241-0272-01
Theophylline	Theophylline anhydrous 450 mg/1	Tablet, Extended releaseOral	Ajanta Pharma USA Inc.	27241-273	27241-0273-01
Theophylline	Theophylline anhydrous 450 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-442	72789-0442-01
Theophylline	Theophylline anhydrous 300 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-441	72789-0441-01
Theophylline	Theophylline anhydrous 300 mg/1	Tablet, Extended releaseOral	Strides Pharma Science Limited	64380-243	64380-0243-01
Theophylline	Theophylline anhydrous 450 mg/1	Tablet, Extended releaseOral	Strides Pharma Science Limited	64380-244	64380-0244-01
Theophylline	Theophylline anhydrous 300 mg/1	Tablet, Extended releaseOral	Harman Finochem Limited	82638-105	82638-0105-02
Theophylline	Theophylline anhydrous 300 mg/1	Tablet, Extended releaseOral	Viona Pharmaceuticals Inc	72578-173	72578-0173-01
Theophylline	Theophylline anhydrous 450 mg/1	Tablet, Extended releaseOral	Viona Pharmaceuticals Inc	72578-174	72578-0174-01
Theophylline	Theophylline anhydrous 300 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1782	70771-1782-01

All 41 Theophylline NDCs

Other NDCs under ANDA 214806

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

FDA NDC Directory listings under ANDA 214806
Product	Strength	Form · route	Labeler	Product NDC
Theophylline	Theophylline anhydrous 300 mg/1	Tablet, Extended releaseOral	Harman Finochem Limited	82638-105