Home NDC 12634-118 Benzphetamine Hydrochloride
Product NDC 12634-118
11-digit product format 126340118
Labeler code 12634
Product ID 12634-118_46efec4f-f86d-0534-e054-00144ff88e88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benzphetamine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Apotheca Inc.
Application ANDA040747
Marketing category ANDA
Marketing start 2010-09-07
Marketing end 0000-00-00
Substance BENZPHETAMINE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 14 · 819 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A040747-001 BENZPHETAMINE HYDROCHLORIDE BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 A040747-002 BENZPHETAMINE HYDROCHLORIDE BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20
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 3 · 84 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 2026-08-18 06:07:40 2026-07 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040747-001 BENZPHETAMINE HYDROCHLORIDE 50MG TABLET / ORAL 2007-03-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040747-002 BENZPHETAMINE HYDROCHLORIDE 25MG TABLET / ORAL 2015-11-20 bb7c543d1eb4…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 12634-118-00 Benzphetamine Hydrochloride 10 in 1 BOTTLE TABLET 10 5 12634-118-01 Benzphetamine Hydrochloride 100 in 1 BOTTLE TABLET 100 5 12634-118-09 Benzphetamine Hydrochloride 35 in 1 BOTTLE TABLET 35 5 12634-118-12 Benzphetamine Hydrochloride 120 in 1 BOTTLE TABLET 120 5 12634-118-18 Benzphetamine Hydrochloride 180 in 1 BOTTLE TABLET 180 5 12634-118-40 Benzphetamine Hydrochloride 40 in 1 BOTTLE TABLET 40 5 12634-118-42 Benzphetamine Hydrochloride 42 in 1 BOTTLE TABLET 42 5 12634-118-45 Benzphetamine Hydrochloride 45 in 1 BOTTLE TABLET 45 5 12634-118-50 Benzphetamine Hydrochloride 50 in 1 BOTTLE TABLET 50 5 12634-118-52 Benzphetamine Hydrochloride 12 in 1 BLISTER PACK TABLET 12 5 12634-118-54 Benzphetamine Hydrochloride 14 in 1 BLISTER PACK TABLET 14 5 12634-118-57 Benzphetamine Hydrochloride 20 in 1 BLISTER PACK TABLET 20 5 12634-118-59 Benzphetamine Hydrochloride 30 in 1 BLISTER PACK TABLET 30 5 12634-118-60 Benzphetamine Hydrochloride 60 in 1 BOTTLE TABLET 60 5 12634-118-61 Benzphetamine Hydrochloride 10 in 1 BLISTER PACK TABLET 10 5 12634-118-63 Benzphetamine Hydrochloride 3 in 1 BLISTER PACK TABLET 3 5 12634-118-66 Benzphetamine Hydrochloride 6 in 1 BLISTER PACK TABLET 6 5 12634-118-67 Benzphetamine Hydrochloride 7 in 1 BLISTER PACK TABLET 7 5 12634-118-69 Benzphetamine Hydrochloride 9 in 1 BLISTER PACK TABLET 9 5 12634-118-71 Benzphetamine Hydrochloride 30 in 1 BOTTLE TABLET 30 5 12634-118-74 Benzphetamine Hydrochloride 24 in 1 BOTTLE TABLET 24 5 12634-118-78 Benzphetamine Hydrochloride 28 in 1 BOTTLE TABLET 28 5 12634-118-79 Benzphetamine Hydrochloride 25 in 1 BOTTLE TABLET 25 5 12634-118-80 Benzphetamine Hydrochloride 20 in 1 BOTTLE TABLET 20 5 12634-118-81 Benzphetamine Hydrochloride 21 in 1 BOTTLE TABLET 21 5 12634-118-82 Benzphetamine Hydrochloride 12 in 1 BOTTLE TABLET 12 5 12634-118-84 Benzphetamine Hydrochloride 14 in 1 BOTTLE TABLET 14 5 12634-118-85 Benzphetamine Hydrochloride 15 in 1 BOTTLE TABLET 15 5 12634-118-90 Benzphetamine Hydrochloride 90 in 1 BOTTLE TABLET 90 5 12634-118-91 Benzphetamine Hydrochloride 1 in 1 BLISTER PACK TABLET 1 5 12634-118-92 Benzphetamine Hydrochloride 2 in 1 BOTTLE TABLET 2 5 12634-118-93 Benzphetamine Hydrochloride 3 in 1 BOTTLE TABLET 3 5 12634-118-94 Benzphetamine Hydrochloride 4 in 1 BOTTLE TABLET 4 5 12634-118-95 Benzphetamine Hydrochloride 95 in 1 BOTTLE TABLET 95 5 12634-118-96 Benzphetamine Hydrochloride 6 in 1 BOTTLE TABLET 6 5 12634-118-97 Benzphetamine Hydrochloride 7 in 1 BOTTLE TABLET 7 5 12634-118-98 Benzphetamine Hydrochloride 8 in 1 BOTTLE TABLET 8 5 12634-118-99 Benzphetamine Hydrochloride 9 in 1 BOTTLE TABLET 9 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12634-118 BENZPHETAMINE HYDROCHLORIDE TABLET [APOTHECA INC.] 5 Legacy NDC, 38 package rows 20170126_e95dfb31-8365-498d-91ea-79738033f905.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 12634-118-00 12634011800 10 in 1 BOTTLE Historical 12634-118-01 12634011801 100 in 1 BOTTLE Historical 12634-118-09 12634011809 35 in 1 BOTTLE Historical 12634-118-12 12634011812 120 in 1 BOTTLE Historical 12634-118-18 12634011818 180 in 1 BOTTLE Historical 12634-118-40 12634011840 40 in 1 BOTTLE Historical 12634-118-42 12634011842 42 in 1 BOTTLE Historical 12634-118-45 12634011845 45 in 1 BOTTLE Historical 12634-118-50 12634011850 50 in 1 BOTTLE Historical 12634-118-52 12634011852 12 in 1 BLISTER PACK Historical 12634-118-54 12634011854 14 in 1 BLISTER PACK Historical 12634-118-57 12634011857 20 in 1 BLISTER PACK Historical 12634-118-59 12634011859 30 in 1 BLISTER PACK Historical 12634-118-60 12634011860 60 in 1 BOTTLE Historical 12634-118-61 12634011861 10 in 1 BLISTER PACK Historical 12634-118-63 12634011863 3 in 1 BLISTER PACK Historical 12634-118-66 12634011866 6 in 1 BLISTER PACK Historical 12634-118-67 12634011867 7 in 1 BLISTER PACK Historical 12634-118-69 12634011869 9 in 1 BLISTER PACK Historical 12634-118-71 12634011871 30 in 1 BOTTLE Historical 12634-118-74 12634011874 24 in 1 BOTTLE Historical 12634-118-78 12634011878 28 in 1 BOTTLE Historical 12634-118-79 12634011879 25 in 1 BOTTLE Historical 12634-118-80 12634011880 20 in 1 BOTTLE Historical 12634-118-81 12634011881 21 in 1 BOTTLE Historical 12634-118-82 12634011882 12 in 1 BOTTLE Historical 12634-118-84 12634011884 14 in 1 BOTTLE Historical 12634-118-85 12634011885 15 in 1 BOTTLE Historical 12634-118-90 12634011890 90 in 1 BOTTLE Historical 12634-118-91 12634011891 1 in 1 BLISTER PACK Historical 12634-118-92 12634011892 2 in 1 BOTTLE Historical 12634-118-93 12634011893 3 in 1 BOTTLE Historical 12634-118-94 12634011894 4 in 1 BOTTLE Historical 12634-118-95 12634011895 95 in 1 BOTTLE Historical 12634-118-96 12634011896 6 in 1 BOTTLE Historical 12634-118-97 12634011897 7 in 1 BOTTLE Historical 12634-118-98 12634011898 8 in 1 BOTTLE Historical 12634-118-99 12634011899 9 in 1 BOTTLE Historical