Home NDC 31722-440 Avanafil
Product NDC 31722-440
11-digit product format 317220440
Labeler code 31722
Product ID 31722-440_46258a47-8730-8397-e063-6394a90a6478
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Avanafil
Dosage form TABLET
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA209266
Marketing category ANDA
Marketing start 2024-06-14
Substance AVANAFIL
Active strength 50 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209266-001 AVANAFIL AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 A209266-002 AVANAFIL AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 A209266-003 AVANAFIL AVANAFIL 200MG TABLET / ORAL AB 2024-06-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
Product history page 1 of 2 · 45 observed 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 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209266-002 AVANAFIL 100MG TABLET / ORAL AB 2024-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209266-003 AVANAFIL 200MG TABLET / ORAL AB 2024-06-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209266-001 AVANAFIL 50MG TABLET / ORAL AB 2024-06-14 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 45 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Avanafil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVANAFIL 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DR5S136IVO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1291306 Internal RxNorm lookup 1291365 Internal RxNorm lookup 1291369 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 31722-440-01 Avanafil 100 in 1 BOTTLE TABLET 100 2 31722-440-30 Avanafil 30 in 1 BOTTLE TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-440 AVANAFIL (AVANAFIL) TABLET [CAMBER PHARMACEUTICALS, INC.] 1 Current NDC, 2 package rows 20241021_1d04e17d-7399-430a-a8bb-fa1912b155e9.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 31722-440-01 31722044001 100 TABLET in 1 BOTTLE (31722-440-01) 100 tablet 2024-06-14 No No Current 31722-440-30 31722044030 30 TABLET in 1 BOTTLE (31722-440-30) 30 tablet 2024-06-14 No No Current