Home NDC 68134-402 tramadol hydrochloride
Product NDC 68134-402
11-digit product format 681340402
Labeler code 68134
Product ID 68134-402_dca135cf-1ae0-a00e-e053-2995a90a1203
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tramadol hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Palmetto Pharmaceuticals, Inc.
Application NDA214044
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2020-09-11
Marketing end 0000-00-00
Substance TRAMADOL HYDROCHLORIDE
Active strength 5 mg/mL
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N214044-001 QDOLO TRAMADOL HYDROCHLORIDE 5MG/ML SOLUTION / ORAL RLD 2020-09-01
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14
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 2026-02-19 14:30 UTC 2026-02 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD 2020-09-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD 2020-09-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD 2020-09-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD 2020-09-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD 2020-09-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD 2020-09-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD 2020-09-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD 2020-09-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD, RS 2020-09-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214044-001 QDOLO 5MG/ML SOLUTION / ORAL RLD 2020-09-01 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 53 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N214044-001 11752103 2040-09-01 U-3197 Drug product 2023-09-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214044-001 11103452 2040-09-01 U-3197 Drug product 2021-09-02 a72a2bbeb626…
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68134-402-05 tramadol hydrochloride 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 5 68134-402-40 tramadol hydrochloride 10 in 1 TRAY SOLUTION 10 5 68134-402-40 tramadol hydrochloride 4 in 1 CASE SOLUTION 4 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68134-402 TRAMADOL HYDROCHLORIDE SOLUTION [PALMETTO PHARMACEUTICALS, INC.] 5 Legacy NDC, 3 package rows 20241210_2804c640-9d47-4b40-b58b-da321b79cf39.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 Marketing end Sample Exclude flag Status 68134-402-05 68134040205 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 68134-402-40 68134040240 4 TRAY in 1 CASE (68134-402-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68134-402-05) 4 tray 2021-09-16 0000-00-00 No No Current