Home NDC 68382-319-77 TRAMADOL HYDROCHLORIDE
Product NDC 68382-319
Requested package NDC 68382-319-77
11-digit product format 683820319
Labeler code 68382
Product ID 68382-319_1e86c1c4-5399-472b-86d1-62e48db2fbd8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TRAMADOL HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA090404
Marketing category ANDA
Marketing start 2011-01-31
Marketing end 0000-00-00
Substance TRAMADOL HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2023-12-31
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 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68382-319 68382-319-77 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68382-319 68382-319-77 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A090404-001 TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090404-001 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.
Product history page 1 of 2 · 42 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 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090404-001 TRAMADOL HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-01-31 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRAMADOL HYDROCHLORIDE ACTIVE INGREDIENT 9N7R477WCK TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 TRAMADOL HYDROCHLORIDE ACTIVE INGREDIENT 9N7R477WCK TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 TRAMADOL ACTIVE MOIETY 39J1LGJ30J TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 TRAMADOL ACTIVE MOIETY 39J1LGJ30J TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 POLYETHYLENE GLYCOL 1000 INACTIVE INGREDIENT U076Q6Q621 TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 TRAMADOL HYDROCHLORIDE ACTIVE INGREDIENT 9N7R477WCK TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX] 1 TRAMADOL ACTIVE MOIETY 39J1LGJ30J TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX] 1 CELLULOSE ACETATE INACTIVE INGREDIENT 3J2P07GVB6 TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRAMADOL HYDROCHLORIDE ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68382-319-77 68382031977 100 BLISTER PACK in 1 CARTON (68382-319-77) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-319-30) 100 blister pack 2011-01-31 0000-00-00 No No Current