Prescription drug · ANDA

Doxepin Hydrochloride NDC 69238-1166

Doxepin hydrochloride 10 mg/1 · Capsule · Oral · Amneal Pharmaceuticals LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)69238-1166Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69238-1166Add 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
69238-1166-1692381166011000 CAPSULE in 1 BOTTLE (69238-1166-1)Marketed from Jun 28, 2017
69238-1166-36923811660330 CAPSULE in 1 BOTTLE (69238-1166-3)Marketed from Jun 28, 2017
69238-1166-96923811660990 CAPSULE in 1 BOTTLE (69238-1166-9)Marketed from Jun 28, 2017

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)
Doxepin Hydrochloride
Generic name (nonproprietary)
doxepin hydrochloride
Active ingredients
Doxepin hydrochloride — 10 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207482
Marketing start
Listing expires
Identifiers
Product ID 69238-1166_dbc8577a-52eb-47c0-b069-2e999ba45f27SPL ID dbc8577a-52eb-47c0-b069-2e999ba45f27
Pharmacologic class
Tricyclic Antidepressant

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

N469238116601 followed by a unit qualifier and the quantity

Package 69238-1166-01. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under ANDA 207482

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

FDA NDC Directory listings under ANDA 207482
ProductStrengthForm · routeLabelerProduct NDC
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralMajor Pharmaceuticals0904-7052
Doxepin HydrochlorideDoxepin hydrochloride 100 mg/1CapsuleOralAmneal Pharmaceuticals LLC69238-1173
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralAmneal Pharmaceuticals LLC69238-1170
Doxepin HydrochlorideDoxepin hydrochloride 50 mg/1CapsuleOralAmneal Pharmaceuticals LLC69238-1171
Doxepin HydrochlorideDoxepin hydrochloride 75 mg/1CapsuleOralAmneal Pharmaceuticals LLC69238-1172
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralMajor Pharmaceuticals0904-7053
Doxepin HydrochlorideDoxepin hydrochloride 50 mg/1CapsuleOralMajor Pharmaceuticals0904-7054
Doxepin HydrochlorideDoxepin hydrochloride 100 mg/1CapsuleOralMajor Pharmaceuticals0904-7055
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralRedpharm Drug67296-2165
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralA-S Medication Solutions50090-8009
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralBryant Ranch Prepack71335-0072

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Doxepin Hydrochloride NDC 69238-1166 | Med-Code