doxepin hydrochloride

Generic: doxepin hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxepin hydrochloride
Generic Name doxepin hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxepin hydrochloride 100 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-4221
Product ID 51672-4221_40d409a6-54af-c970-e063-6394a90aa1cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213063
Marketing Start 2020-07-01
Marketing End 2026-03-31

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516724221
Hyphenated Format 51672-4221

Supplemental Identifiers

RxCUI
1000048 1000058 1000070 1000076 1000097
UPC
0351672421816 0351672421915 0351672422011
UNII
3U9A0FE9N5

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name doxepin hydrochloride (source: ndc)
Generic Name doxepin hydrochloride (source: ndc)
Application Number ANDA213063 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • HOW SUPPLIED Doxepin Hydrochloride Capsules, USP are available containing doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg or 100 mg of doxepin. The 10 mg capsule is a hard-shell, gelatin capsule with a tan opaque cap and tan opaque body, axially printed with TARO over D10 in black ink on both the cap and the body. They are available as follows: NDC 51672-4217-1 bottles of 100 capsules The 25 mg capsule is a hard-shell, gelatin capsule with a yellow opaque cap and white opaque body, axially printed with TARO over D25 in black ink on both the cap and the body. They are available as follows: NDC 51672-4218-1 bottles of 100 capsules The 50 mg capsule is a hard-shell, gelatin capsule with a yellow opaque cap and yellow opaque body, axially printed with TARO over D50 in black ink on both the cap and the body. They are available as follows: NDC 51672-4219-1 bottles of 100 capsules The 75 mg capsule is a hard-shell, gelatin capsule with a green opaque cap and green opaque body, axially printed with TARO over D75 in black ink on both the cap and the body. They are available as follows: NDC 51672-4220-1 bottles of 100 capsules The 100 mg capsule is a hard-shell, gelatin capsule with a green opaque cap and white opaque body, axially printed with TARO over D100 in black ink on both the cap and the body. They are available as follows: NDC 51672-4221-1 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • PRINCIPAL DISPLAY PANEL - 10 mg Capsule Bottle Label NDC 51672-4217-1 100 Capsules Doxepin HCl Capsules, USP 10 mg* Rx only PHARMACIST: Dispense Medication Guide to each patient. Print Medication Guides at: www.taro.com TARO PRINCIPAL DISPLAY PANEL - 10 mg Capsule Bottle Label
  • PRINCIPAL DISPLAY PANEL - 25 mg Capsule Bottle Label NDC 51672-4218-1 100 Capsules Doxepin HCl Capsules, USP 25 mg* Rx only PHARMACIST: Dispense Medication Guide to each patient. Print Medication Guides at: www.taro.com TARO PRINCIPAL DISPLAY PANEL - 25 mg Capsule Bottle Label
  • PRINCIPAL DISPLAY PANEL - 50 mg Capsule Bottle Label NDC 51672-4219-1 100 Capsules Doxepin HCl Capsules, USP 50 mg* Rx only PHARMACIST: Dispense Medication Guide to each patient. Print Medication Guides at: www.taro.com TARO PRINCIPAL DISPLAY PANEL - 50 mg Capsule Bottle Label
  • PRINCIPAL DISPLAY PANEL - 75 mg Capsule Bottle Label NDC 51672-4220-1 100 Capsules Doxepin HCl Capsules, USP 75 mg* Rx only PHARMACIST: Dispense Medication Guide to each patient. Print Medication Guides at: www.taro.com TARO PRINCIPAL DISPLAY PANEL - 75 mg Capsule Bottle Label
  • PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label NDC 51672-4221-1 100 Capsules Doxepin HCl Capsules, USP 100 mg* Rx only PHARMACIST: Dispense Medication Guide to each patient. Print Medication Guides at: www.taro.com TARO PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label
source: label

Packages (0)

No package records.

Ingredients (1)

doxepin hydrochloride (100 mg/1)

Linked Drug Pages (1)

DOXEPIN HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40d409a6-54af-c970-e063-6394a90aa1cf", "openfda": {"upc": ["0351672421816", "0351672421915", "0351672422011"], "unii": ["3U9A0FE9N5"], "rxcui": ["1000048", "1000058", "1000070", "1000076", "1000097"], "spl_set_id": ["e5f35807-3db1-4387-8c37-693d9170b51b"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "DOXEPIN HYDROCHLORIDE", "product_id": "51672-4221_40d409a6-54af-c970-e063-6394a90aa1cf", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "51672-4221", "generic_name": "DOXEPIN HYDROCHLORIDE", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOXEPIN HYDROCHLORIDE", "active_ingredients": [{"name": "DOXEPIN HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA213063", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20200701"}