What is NDC 0121-4820?

0121-4820 is the product NDC for Theophylline, Theophylline 80 mg/15mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.

PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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 0121-4820 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-4820Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-4820Add 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
0121-4820-40	00121482040	4 TRAY in 1 CASE (0121-4820-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4820-15)Marketed from Dec 16, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 80 mg/15mL
Dosage form: Solution
Route: Oral
Labeler: PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206344
Marketing start: Dec 16, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Xanthines (Chemical structure)
Identifiers: Product ID 0121-4820_895f63e5-665b-4227-8e44-6971ba5ce294SPL ID 895f63e5-665b-4227-8e44-6971ba5ce294SPL set ID 32b9780f-c46f-4e0f-9641-2cab60600e6eRxCUI 313306UNII C137DTR5RG
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

N400121482040 followed by a unit qualifier and the quantity

Package 00121-4820-40. 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 Nov 19, 2024.

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)

About NDC 0121-4820

What is NDC 0121-4820?: 0121-4820 is the product NDC for Theophylline, Theophylline 80 mg/15mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. 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.
Who is the labeler?: PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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 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	PD-Rx Pharmaceuticals, Inc.	72789-441	72789-0441-01
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	Harman Finochem Limited	82638-105	82638-0105-02
Theophylline	Theophylline anhydrous 450 mg/1	Tablet, Extended releaseOral	Harman Finochem Limited	82638-106	82638-0106-02
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

All 41 Theophylline NDCs

Other NDCs under ANDA 206344

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

FDA NDC Directory listings under ANDA 206344
Product	Strength	Form · route	Labeler	Product NDC
Theophylline	Theophylline 80 mg/15mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-0820