Doxepin Tablets, For Oral Use

SPL v3

SPL

SPL Set ID 1461ede6-24f0-42a1-b801-0cf4ef404985

Route

ORAL

Published

Effective Date 2024-06-12

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Doxepin (3 mg)

Inactive Ingredients

Fd&c Blue No. 1 Lactose Monohydrate Magnesium Stearate Sodium Starch Glycolate Type A Potato Starch, Corn Talc D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance

Imprint: 394 Shape: round Color: blue Color: green Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2024-06-30

Description

NDC 70771-1528-3 in bottle of 30 tablets Doxepin Tablets, 3 mg Rx only 30 tablets NDC 70771-1529-3 in bottle of 30 tablets Doxepin Tablets, 6 mg Rx only 30 tablets

Medication Information

Description

NDC 70771-1528-3 in bottle of 30 tablets Doxepin Tablets, 3 mg Rx only 30 tablets NDC 70771-1529-3 in bottle of 30 tablets Doxepin Tablets, 6 mg Rx only 30 tablets

Package Label.principal Display Panel

NDC 70771-1528-3 in bottle of 30 tablets

Doxepin Tablets, 3 mg

Rx only

30 tablets

NDC 70771-1529-3 in bottle of 30 tablets

Doxepin Tablets, 6 mg

Rx only

30 tablets

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 70771-1528-3 in bottle of 30 tablets

Doxepin Tablets, 3 mg

Rx only

30 tablets

NDC 70771-1529-3 in bottle of 30 tablets

Doxepin Tablets, 6 mg

Rx only

30 tablets

Advanced Ingredient Data

[{"name": "DOXEPIN", "unii": "5ASJ6HUZ7D", "classCode": "ACTIM", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DOXEPIN", "unii": "5ASJ6HUZ7D", "classCode": "ACTIM", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1528-3 in bottle of 30 tablets Doxepin Tablets, 3 mg Rx only 30 tablets NDC 70771-1529-3 in bottle of 30 tablets Doxepin Tablets, 6 mg Rx only 30 tablets"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:44:47.677675 · Updated: 2026-03-14T22:21:12.024926