NDC codes

FDA NDC Directory
Product NDC (as listed)68382-910Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68382-0910Add 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
68382-910-106838209101010 VIAL in 1 CARTON (68382-910-10) / 10 mL in 1 VIALMarketed from Feb 1, 2018

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)
Doxycycline
Generic name (nonproprietary)
doxycycline
Active ingredients
Doxycycline hyclate — 100 mg/10mL
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
Labeler
Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207757
Marketing start
Listing expires
Other FDA classes
Tetracyclines (Chemical structure)
Identifiers
Product ID 68382-910_b99072cd-f6d8-4d24-9014-f76e327dd6d3SPL ID b99072cd-f6d8-4d24-9014-f76e327dd6d3SPL set ID 7ce80f6e-3c0d-4978-b626-5fd3f3ff349eRxCUI 310027, 1998483UNII 19XTS3T51UUPC 0368382911018
Pharmacologic class
Tetracycline-class Drug

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468382091010 followed by a unit qualifier and the quantity

Package 68382-0910-10. 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 To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline for injection and other antibacterial drugs, doxycycline for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is indicated in infections caused by the following microorganisms: Rickettsiae (Rocky Mountain spotted fever, typhus feve…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-910

What is NDC 68382-910?
68382-910 is the product NDC for Doxycycline, Doxycycline hyclate 100 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Doxycycline.
What is the active ingredient?
Doxycycline hyclate.
Who is the labeler?
Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Doxycycline?
135 other product NDCs are listed under this name. See all Doxycycline 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 Doxycycline NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DoxycyclineDoxycycline 100 mg/1CapsuleOralREMEDYREPACK INC.70518-476270518-4762-00
doxycyclineDoxycycline 50 mg/1CapsuleOralSafecor Health, LLC48433-15848433-0158-03
doxycyclineDoxycycline 100 mg/1CapsuleOralSafecor Health, LLC48433-15948433-0159-03
doxycyclineDoxycycline 100 mg/1CapsuleOralCoupler LLC67046-126067046-1260-03
doxycyclineDoxycycline hyclate 100 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-417668788-4176-0068788-4176-0168788-4176-02+3 more
doxycyclineDoxycycline hyclate 100 mg/1CapsuleOralREMEDYREPACK INC.70518-465570518-4655-0070518-4655-01
DoxycyclineDoxycycline hyclate 100 mg/100mgInjection, Powder, Lyophilized, For solutionIntravenousSteriscience Specialties Private Limited82449-00882449-0008-02
DoxycyclineDoxycycline 100 mg/1CapsuleOralAmerican Health Packaging60687-94360687-0943-21
DoxycyclineDoxycycline hyclate 100 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousJVET PHARMACEUTICALS LLC86211-11686211-0116-10
DoxycyclineDoxycycline 40 mg/1CapsuleOralAiPing Pharmaceutical, Inc.11788-13411788-0134-30

All 136 Doxycycline NDCs

Other NDCs under ANDA 207757

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

FDA NDC Directory listings under ANDA 207757
ProductStrengthForm · routeLabelerProduct NDC
DoxycyclineDoxycycline hyclate 200 mg/20mLInjection, Powder, Lyophilized, For solutionIntravenousZydus Pharmaceuticals USA Inc.68382-911
DoxycyclineDoxycycline hyclate 100 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousZydus Lifesciences Limited70771-1121
DoxycyclineDoxycycline hyclate 200 mg/20mLInjection, Powder, Lyophilized, For solutionIntravenousZydus Lifesciences Limited70771-1122

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