NDC codes

FDA NDC Directory
Product NDC (as listed)0378-0873Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00378-0873Add 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
0378-0873-9900378087399003780873994 POUCH in 1 CARTON (0378-0873-99) / 1 PATCH in 1 POUCH (0378-0873-16) / 7 d in 1 PATCHMarketed from Mar 1, 2013

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)
Clonidine
Generic name (nonproprietary)
clonidine
Active ingredients
Clonidine — .3 mg/d
Dosage form
Patch
Route
Transdermal
Labeler
Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076166
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha2-Agonists (Mechanism)
Identifiers
Product ID 0378-0873_40bd0d20-4e93-4e54-b43b-5ba52eb416faSPL ID 40bd0d20-4e93-4e54-b43b-5ba52eb416faSPL set ID 7adfc439-e6d0-4593-87dd-0eef36d33c6dRxCUI 998671, 998675, 998679UNII MN3L5RMN02
Pharmacologic class
Central alpha-2 Adrenergic 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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400378087399 followed by a unit qualifier and the quantity

Package 00378-0873-99. 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 Clonidine transdermal system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-0873

What is NDC 0378-0873?
0378-0873 is the product NDC for Clonidine, Clonidine .3 mg/d patch, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Clonidine.
What is the active ingredient?
Clonidine.
Who is the labeler?
Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clonidine?
11 other product NDCs are listed under this name. See all Clonidine 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 Clonidine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ClonidineClonidine .1 mg/24hPatch, Extended releaseTransdermalDr. Reddy's Labratories Inc.75907-02375907-0023-48
ClonidineClonidine .2 mg/24hPatch, Extended releaseTransdermalDr. Reddy's Labratories Inc.75907-02475907-0024-48
ClonidineClonidine .3 mg/24hPatch, Extended releaseTransdermalDr. Reddy's Labratories Inc.75907-02575907-0025-48
ClonidineClonidine .17 mg/1Tablet, Extended releaseOralTruPharma, LLC52817-37552817-0375-30
ClonidineClonidine .17 mg/1Tablet, Extended releaseOralPALMETTO PHARMACEUTICALS INC.68134-60368134-0603-30
ClonidineClonidine hydrochloride .1 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-24750742-0247-0550742-0247-3050742-0247-60
ClonidineClonidine .3 mg/24hPatch, Extended releaseTransdermalMayne Pharma Inc.51862-455—
ClonidineClonidine hydrochloride 100 ug/mLInjection, SolutionEpiduralXGen Pharmaceuticals DJB, Inc.39822-200039822-2000-01
ClonidineClonidine hydrochloride 500 ug/mLInjection, SolutionEpiduralXGen Pharmaceuticals DJB, Inc.39822-201039822-2010-01
ClonidineClonidine .2 mg/dPatchTransdermalMylan Pharmaceuticals Inc.0378-087200378-0872-99

All 12 Clonidine NDCs

Other NDCs under ANDA 076166

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

FDA NDC Directory listings under ANDA 076166
ProductStrengthForm · routeLabelerProduct NDC
ClonidineClonidine .1 mg/dPatchTransdermalMylan Pharmaceuticals Inc.0378-0871
ClonidineClonidine .2 mg/dPatchTransdermalMylan Pharmaceuticals Inc.0378-0872

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