Home NDC 51672-1404-2 Doxepin Hydrochloride
Product NDC 51672-1404
Requested package NDC 51672-1404-2
11-digit product format 516721404
Labeler code 51672
Product ID 51672-1404_5c03e1c3-1884-0855-e063-6294a90a8a1b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxepin Hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA213919
Marketing category ANDA
Marketing start 2026-09-30
Substance DOXEPIN HYDROCHLORIDE
Active strength 50 mg/g
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213919-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2026-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213919-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A213919-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2026-04-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 A213919-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2026-04-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213919-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2026-04-28 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213919-001 DOXEPIN HYDROCHLORIDE 5% CREAM / TOPICAL AB 2026-04-28 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Doxepin Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXEPIN HYDROCHLORIDE 50 mg/g
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51672-1404-2 51672140402 1 TUBE in 1 CARTON (51672-1404-2) / 30 g in 1 TUBE 1 tube 2026-09-30 No No Current