NDC codes

FDA NDC Directory
Product NDC (as listed)27808-033Labeler and product segments. Claims need a package NDC.
Product NDC at billing width27808-0033Add 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
27808-033-012780800330127808003301473 mL in 1 BOTTLE (27808-033-01)Marketed from Aug 2, 2012

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 — 80 mg/15mL
Dosage form
Solution
Route
Oral
Labeler
Cranbury Pharmaceuticals, LLCNDC labeler code 27808
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091586
Marketing start
Listing expires
Other FDA classes
Xanthines (Chemical structure)
Identifiers
Product ID 27808-033_723b1708-84c4-4a42-99bb-475c77bed2efSPL ID 723b1708-84c4-4a42-99bb-475c77bed2efSPL set ID 78a99bfe-6ebe-4ace-80b0-ee019921435eRxCUI 313306UNII 0I55128JYKUPC 0327808033017
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

N427808003301 followed by a unit qualifier and the quantity

Package 27808-0033-01. 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 oral solution 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 27808-033

What is NDC 27808-033?
27808-033 is the product NDC for Theophylline, Theophylline anhydrous 80 mg/15mL solution, listed with the FDA by Cranbury Pharmaceuticals, LLC. 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?
Cranbury Pharmaceuticals, LLC, NDC labeler code 27808. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TheophyllineTheophylline anhydrous 300 mg/1Tablet, Extended releaseOralAjanta Pharma USA Inc.27241-27227241-0272-01
TheophyllineTheophylline anhydrous 450 mg/1Tablet, Extended releaseOralAjanta Pharma USA Inc.27241-27327241-0273-01
TheophyllineTheophylline anhydrous 450 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-44272789-0442-01
TheophyllineTheophylline anhydrous 300 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-44172789-0441-01
TheophyllineTheophylline anhydrous 300 mg/1Tablet, Extended releaseOralStrides Pharma Science Limited64380-24364380-0243-01
TheophyllineTheophylline anhydrous 450 mg/1Tablet, Extended releaseOralStrides Pharma Science Limited64380-24464380-0244-01
TheophyllineTheophylline anhydrous 300 mg/1Tablet, Extended releaseOralHarman Finochem Limited82638-10582638-0105-02
TheophyllineTheophylline anhydrous 450 mg/1Tablet, Extended releaseOralHarman Finochem Limited82638-10682638-0106-02
TheophyllineTheophylline anhydrous 300 mg/1Tablet, Extended releaseOralViona Pharmaceuticals Inc72578-17372578-0173-01
TheophyllineTheophylline anhydrous 450 mg/1Tablet, Extended releaseOralViona Pharmaceuticals Inc72578-17472578-0174-01

All 41 Theophylline NDCs

Other NDCs under ANDA 091586

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

FDA NDC Directory listings under ANDA 091586
ProductStrengthForm · routeLabelerProduct NDC
TheophyllineTheophylline anhydrous 80 mg/15mLSolutionOralATLANTIC BIOLOGICALS CORP.17856-0038
TheophyllineTheophylline anhydrous 80 mg/15mLSolutionOralBryant Ranch Prepack71335-2909
TheophyllineTheophylline anhydrous 80 mg/15mLSolutionOralBryant Ranch Prepack72162-2038

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