Tramadol Hydrochloride

Product NDC: 52817-615
11-digit product format: 528170615
Labeler code: 52817
Product ID: 52817-615_f7fd27bd-cd40-704c-e053-6394a90a6a6f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tramadol hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: TruPharma, LLC
Application: NDA214044
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-09-11
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: 2026-12-31
Current FDA listing: Yes

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	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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tramadol Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRAMADOL HYDROCHLORIDE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9N7R477WCK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2395808	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
aea56ff9-94ac-47a8-8f15-8790d538973b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
43d017e1-6ae6-7555-71d1-c249236d6f26	Product name	4	20251117
bff1fbab-f4cc-4993-b7de-2b555ee5eb73	Product name	1	20220509
c563c906-2606-457c-bb1b-5a623daed55b	Product name	1	20210511
43a9f8f9-34aa-8ae8-719e-5489454f7720	Product name	5	20200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75	Product name	1	20190927
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
9457302e-0ca3-d9ff-0863-1b24b6107218	Product name	1	20140508
d5c49867-1fe9-7a44-3319-814417011d51	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52817-615-16	Tramadol Hydrochloride	473 mL in 1 BOTTLE	SOLUTION	473		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52817-615-16	ML - Milliliter	52817-615	4c46296b-076f-40e2-97c5-4cb1e3644755	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52817-615	TRAMADOL HYDROCHLORIDE SOLUTION [TRUPHARMA, LLC]	1	Current NDC, 1 package rows	20230329_aea56ff9-94ac-47a8-8f15-8790d538973b.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	TruPharma, LLC	aea56ff9-94ac-47a8-8f15-8790d538973b	2023-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 214044 application number: NDA214044 ndc (product): 52817-615

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9N7R477WCK	TRAMADOL HYDROCHLORIDE	36282-47-0	TRAMADOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2395808	traMADol hydrochloride 5 MG in 1 mL Oral Solution	PSN	aea56ff9-94ac-47a8-8f15-8790d538973b	1
2395808	tramadol hydrochloride 5 MG/ML Oral Solution	SCD	aea56ff9-94ac-47a8-8f15-8790d538973b	1
2395808	tramadol hydrochloride 5 MG per 1 ML Oral Solution	SY	aea56ff9-94ac-47a8-8f15-8790d538973b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
52817-615-16	52817061516	473 mL in 1 BOTTLE (52817-615-16)	473 ml	2023-01-25	No	No	Current