Home NDC 49483-946 Benzonatate 100 mg
Product NDC 49483-946
11-digit product format 494830946
Labeler code 49483
Product ID 49483-946_5adfd35d-e709-e09a-e063-6394a90af04e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benzonatate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler TIME CAP LABORATORIES, INC
Application ANDA220298
Marketing category ANDA
Marketing start 2026-09-14
Substance BENZONATATE
Active strength 100 mg/1
Pharmacologic classes Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220298-001 BENZONATATE BENZONATATE 100MG CAPSULE / ORAL AA 2026-03-30 A220298-002 BENZONATATE BENZONATATE 200MG CAPSULE / ORAL AA 2026-03-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-09-14 22:38:34 2026-08 A220298-001 BENZONATATE 100MG CAPSULE / ORAL AA 2026-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220298-002 BENZONATATE 200MG CAPSULE / ORAL AA 2026-03-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220298-001 BENZONATATE 100MG CAPSULE / ORAL AA 2026-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220298-002 BENZONATATE 200MG CAPSULE / ORAL AA 2026-03-30 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220298-001 BENZONATATE 100MG CAPSULE / ORAL AA 2026-03-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220298-002 BENZONATATE 200MG CAPSULE / ORAL AA 2026-03-30 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 Benzonatate 100 mg
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZONATATE 100 mg/1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 49483-946-01 49483094601 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-946-01) 2026-09-14 No No Current 49483-946-50 49483094650 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-946-50) 2026-09-14 No No Current