What is NDC 60219-2045?

60219-2045 is the product NDC for theophylline, Theophylline anhydrous 300 mg/1 tablet, extended release, listed with the FDA by Amneal Pharmaceuticals LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals LLC, NDC labeler code 60219. 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 60219-2045 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)60219-2045Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60219-2045Add 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
60219-2045-1	6021920450160219204501	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-1)Marketed from Mar 27, 2023
60219-2045-3	6021920450360219204503	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-3)Marketed from Mar 27, 2023
60219-2045-5	6021920450560219204505	500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-5)Marketed from Mar 27, 2023
60219-2045-7	6021920450760219204507	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-7)Marketed from Mar 27, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Labeler: Amneal Pharmaceuticals LLCNDC labeler code 60219
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216276
Marketing start: Mar 27, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Xanthines (Chemical structure)
Identifiers: Product ID 60219-2045_e6570a39-4967-4ea9-a6e6-8108bd9d72a4SPL ID e6570a39-4967-4ea9-a6e6-8108bd9d72a4
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

N460219204501 followed by a unit qualifier and the quantity

Package 60219-2045-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 60219-2045

What is NDC 60219-2045?: 60219-2045 is the product NDC for theophylline, Theophylline anhydrous 300 mg/1 tablet, extended release, listed with the FDA by Amneal Pharmaceuticals LLC. It has 4 package NDCs, 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?: Amneal Pharmaceuticals LLC, NDC labeler code 60219. 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 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 216276

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

FDA NDC Directory listings under ANDA 216276
Product	Strength	Form · route	Labeler	Product NDC
theophylline	Theophylline anhydrous 450 mg/1	Tablet, Extended releaseOral	Amneal Pharmaceuticals LLC	60219-2046