NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8405Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8405Add 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
68788-8405-1687888405016878884050115 CAPSULE in 1 BOTTLE (68788-8405-1)Marketed from Mar 29, 2023
68788-8405-2687888405026878884050220 CAPSULE in 1 BOTTLE (68788-8405-2)Marketed from Mar 29, 2023
68788-8405-3687888405036878884050330 CAPSULE in 1 BOTTLE (68788-8405-3)Marketed from Mar 29, 2023
68788-8405-6687888405066878884050660 CAPSULE in 1 BOTTLE (68788-8405-6)Marketed from Mar 29, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Benzonatate
Generic name (nonproprietary)
benzonatate
Active ingredients
Benzonatate — 200 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040597
Marketing start
Listing expires
Other FDA classes
Decreased Tracheobronchial Stretch Receptor Activity (Physiologic effect)
Identifiers
Product ID 68788-8405_1f2c1b46-90b1-4d9a-b5a7-77aeb01ce292SPL ID 1f2c1b46-90b1-4d9a-b5a7-77aeb01ce292SPL set ID 6f7f4a31-99ec-45ca-84d7-0be3640d1e0bRxCUI 283417UNII 5P4DHS6ENR
Pharmacologic class
Non-narcotic Antitussive

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

N468788840501 followed by a unit qualifier and the quantity

Package 68788-8405-01. 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 Benzonatate capsules are indicated for the symptomatic relief of cough.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8405

What is NDC 68788-8405?
68788-8405 is the product NDC for Benzonatate, Benzonatate 200 mg/1 capsule, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Benzonatate.
What is the active ingredient?
Benzonatate.
Who is the labeler?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Benzonatate?
134 other product NDCs are listed under this name. See all Benzonatate 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 Benzonatate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
BenzonatateBenzonatate 100 mg/1CapsuleOralStrides Pharma Science Limited64380-71264380-0712-0664380-0712-07
BenzonatateBenzonatate 200 mg/1CapsuleOralStrides Pharma Science Limited64380-71364380-0713-0664380-0713-07
BenzonatateBenzonatate 150 mg/1CapsuleOralAnvi Pharmaceuticals Inc87519-11187519-0111-90
BenzonatateBenzonatate 100 mg/1CapsuleOralREMEDYREPACK INC.70518-455870518-4558-0070518-4558-0170518-4558-02+1 more
BenzonatateBenzonatate 100 mg/1CapsuleOralCoupler LLC67046-162967046-1629-03
BenzonatateBenzonatate 200 mg/1CapsuleOralREMEDYREPACK INC.70518-449770518-4497-0070518-4497-01
BenzonatateBenzonatate 100 mg/1CapsuleOralSt. Mary's Medical Park Pharmacy60760-86960760-0869-1560760-0869-30
BenzonatateBenzonatate 100 mg/1CapsuleOralCoupler LLC67046-148467046-1484-03
BenzonatateBenzonatate 200 mg/1CapsuleOralDirect_rx72189-60672189-0606-2072189-0606-30
BenzonatateBenzonatate 100 mg/1Capsule, Liquid filledOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-89823155-0898-0123155-0898-05

All 135 Benzonatate NDCs

Other NDCs under ANDA 040597

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

FDA NDC Directory listings under ANDA 040597
ProductStrengthForm · routeLabelerProduct NDC
BenzonatateBenzonatate 200 mg/1Capsule, Liquid filledOralZydus Pharmaceuticals USA Inc.68382-091
BenzonatateBenzonatate 100 mg/1CapsuleOralZydus Lifesciences Limited65841-614
BenzonatateBenzonatate 100 mg/1CapsuleOralA-S Medication Solutions50090-6387
BenzonatateBenzonatate 100 mg/1CapsuleOralBryant Ranch Prepack71335-0091
BenzonatateBenzonatate 100 mg/1Capsule, Liquid filledOralZydus Pharmaceuticals USA Inc.68382-247
BenzonatateBenzonatate 200 mg/1CapsuleOralBryant Ranch Prepack71335-2790
BenzonatateBenzonatate 200 mg/1CapsuleOralBryant Ranch Prepack71335-2590
BenzonatateBenzonatate 100 mg/1CapsuleOralAmerican Health Packaging68084-214
BenzonatateBenzonatate 200 mg/1CapsuleOralRedpharm Drug67296-2153
BenzonatateBenzonatate 100 mg/1CapsuleOralA-S Medication Solutions50090-6850
BenzonatateBenzonatate 100 mg/1Capsule, Liquid filledOralMajor Pharmaceuticals0904-6564
BenzonatateBenzonatate 200 mg/1CapsuleOralZydus Lifesciences Limited65841-843
BenzonatateBenzonatate 100 mg/1CapsuleOralDIRECT RX61919-400
BenzonatateBenzonatate 100 mg/1CapsuleOralProficient Rx LP63187-799

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