NDC codes

FDA NDC Directory
Product NDC (as listed)82804-942Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82804-0942Add 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
82804-942-0082804094200100 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-942-00)Marketed from Sep 17, 2026
82804-942-308280409423030 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-942-30)Marketed from Sep 17, 2026
82804-942-608280409426060 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-942-60)Marketed from Sep 17, 2026
82804-942-7282804094272120 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-942-72)Marketed from Sep 17, 2026
82804-942-908280409429090 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-942-90)Marketed from Sep 17, 2026

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 (Anhydrous)Suffix: (Anhydrous)
Generic name (nonproprietary)
theophylline anhydrous
Active ingredients
Theophylline anhydrous — 600 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040560
Marketing start
Listing expires
Other FDA classes
Xanthines (Chemical structure)
Identifiers
Product ID 82804-942_882657ae-e15b-4c86-a571-b55460bd4726SPL ID 882657ae-e15b-4c86-a571-b55460bd4726
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

N482804094200 followed by a unit qualifier and the quantity

Package 82804-0942-00. 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.

Other NDCs under ANDA 040560

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

FDA NDC Directory listings under ANDA 040560
ProductStrengthForm · routeLabelerProduct NDC
Theophylline (Anhydrous)theophylline anhydrousTheophylline anhydrous 400 mg/1Tablet, Extended releaseOralWestminster Pharmaceuticals, LLC69367-414
Theophylline (Anhydrous)theophylline anhydrousTheophylline anhydrous 600 mg/1Tablet, Extended releaseOralWestminster Pharmaceuticals, LLC69367-415
Theophylline (Anhydrous)theophyllineTheophylline anhydrous 400 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-318
Theophylline (Anhydrous)theophyllineTheophylline anhydrous 600 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-319
Theophylline (Anhydrous)theophylline anhydrousTheophylline anhydrous 400 mg/1Tablet, Extended releaseOralProficient Rx LP82804-941

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