NDC codes

FDA NDC Directory
Product NDC (as listed)47781-413Labeler and product segments. Claims need a package NDC.
Product NDC at billing width47781-0413Add 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
47781-413-60477810413604778104136060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47781-413-60)Marketed from Jan 21, 2020

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)
Hydrocodone Bitartrate
Generic name (nonproprietary)
hydrocodone bitartrate
Active ingredients
Hydrocodone bitartrate — 40 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Labeler
Alvogen Inc.NDC labeler code 47781
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206986
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Opioid Agonists (Mechanism)
Identifiers
Product ID 47781-413_3bdd85f7-51e5-bd1a-ad5c-f23a7bf0ea7cSPL ID 3bdd85f7-51e5-bd1a-ad5c-f23a7bf0ea7c
Pharmacologic class
Opioid Agonist

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

N447781041360 followed by a unit qualifier and the quantity

Package 47781-0413-60. 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 47781-413

What is NDC 47781-413?
47781-413 is the product NDC for Hydrocodone Bitartrate, Hydrocodone bitartrate 40 mg/1 capsule, extended release, listed with the FDA by Alvogen Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Hydrocodone Bitartrate.
What is the active ingredient?
Hydrocodone bitartrate.
Who is the labeler?
Alvogen Inc., NDC labeler code 47781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hydrocodone Bitartrate?
12 other product NDCs are listed under this name. See all Hydrocodone Bitartrate 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 Hydrocodone Bitartrate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Hydrocodone BitartrateHydrocodone bitartrate 20 mg/1Tablet, Extended releaseOralAlvogen Inc.47781-39247781-0392-60
Hydrocodone BitartrateHydrocodone bitartrate 30 mg/1Tablet, Extended releaseOralAlvogen Inc.47781-39347781-0393-60
Hydrocodone BitartrateHydrocodone bitartrate 40 mg/1Tablet, Extended releaseOralAlvogen Inc.47781-39447781-0394-60
Hydrocodone BitartrateHydrocodone bitartrate 60 mg/1Tablet, Extended releaseOralAlvogen Inc.47781-39547781-0395-60
Hydrocodone BitartrateHydrocodone bitartrate 80 mg/1Tablet, Extended releaseOralAlvogen Inc.47781-39647781-0396-60
Hydrocodone BitartrateHydrocodone bitartrate 100 mg/1Tablet, Extended releaseOralAlvogen Inc.47781-39747781-0397-60
Hydrocodone BitartrateHydrocodone bitartrate 120 mg/1Tablet, Extended releaseOralAlvogen Inc.47781-39847781-0398-60
Hydrocodone BitartrateHydrocodone bitartrate 10 mg/1Capsule, Extended releaseOralAlvogen Inc.47781-40947781-0409-60
Hydrocodone BitartrateHydrocodone bitartrate 15 mg/1Capsule, Extended releaseOralAlvogen Inc.47781-41047781-0410-60
Hydrocodone BitartrateHydrocodone bitartrate 20 mg/1Capsule, Extended releaseOralAlvogen Inc.47781-41147781-0411-60

All 13 Hydrocodone Bitartrate NDCs

Other NDCs under ANDA 206986

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

FDA NDC Directory listings under ANDA 206986
ProductStrengthForm · routeLabelerProduct NDC
Hydrocodone BitartrateHydrocodone bitartrate 10 mg/1Capsule, Extended releaseOralAlvogen Inc.47781-409
Hydrocodone BitartrateHydrocodone bitartrate 15 mg/1Capsule, Extended releaseOralAlvogen Inc.47781-410
Hydrocodone BitartrateHydrocodone bitartrate 20 mg/1Capsule, Extended releaseOralAlvogen Inc.47781-411
Hydrocodone BitartrateHydrocodone bitartrate 30 mg/1Capsule, Extended releaseOralAlvogen Inc.47781-412
Hydrocodone BitartrateHydrocodone bitartrate 50 mg/1Capsule, Extended releaseOralAlvogen Inc.47781-414

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