Tramadol Hydrochloride

Product NDC: 64980-614
11-digit product format: 649800614
Labeler code: 64980
Product ID: 64980-614_4a3ae814-06d8-4776-893b-db30c3d19ab6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA075968
Marketing category: ANDA
Marketing start: 2024-08-05
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: 2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075968-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-25
A075968-002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2024-08-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075968-001	AB
A075968-002	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 · 53 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075968-002	TRAMADOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2024-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075968-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL		2002-06-25	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075968-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075968-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075968-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075968-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075968-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075968-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075968-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075968-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075968-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075968-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075968-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075968-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075968-002	AB	1	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075968-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075968-002	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tramadol Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRAMADOL HYDROCHLORIDE	50 mg/1

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
835603	Internal RxNorm lookup
2179635	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
b5852b90-e415-47ef-8f73-87266b58e033	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	SPL version
64980-614-01	Tramadol Hydrochloride	100 in 1 BOTTLE	TABLET	100	4
64980-614-10	Tramadol Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	4
64980-614-50	Tramadol Hydrochloride	500 in 1 BOTTLE	TABLET	500	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-614-01	EA - Each	64980-614	b7261ef4-848e-4fac-a898-bf8929e6a60d	1	2024-12-10
64980-614-10	EA - Each	64980-614	ddf2e409-1c8c-4ce4-a3ca-21572b4d91ae	1	2026-01-08
64980-614-50	EA - Each	64980-614	e467629d-2fc5-4eab-b877-d083af0cd952	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64980-614	TRAMADOL HYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.]	2	Current NDC, 3 package rows	20241028_b5852b90-e415-47ef-8f73-87266b58e033.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	42de8c3a-0441-5d46-e063-6294a90a2079	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075968 application number: ANDA075968
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	552e5b32-accf-29dd-e063-6294a90a4fcf	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075968 application number: ANDA075968
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	515baa9a-b226-4bbe-be87-f9befdf1c9e1	2026-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075968 application number: ANDA075968
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	855905c7-1481-4b2d-a318-3254ad8ed73c	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075968 application number: ANDA075968
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Rising Pharma Holdings, Inc.	b5852b90-e415-47ef-8f73-87266b58e033	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075968 application number: ANDA075968 ndc (product): 64980-614

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
835603	traMADol HCl 50 MG Oral Tablet	PSN	42de8c3a-0441-5d46-e063-6294a90a2079	6
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	42de8c3a-0441-5d46-e063-6294a90a2079	6
2179635	traMADol HCl 100 MG Oral Tablet	PSN	b5852b90-e415-47ef-8f73-87266b58e033	4
835603	traMADol HCl 50 MG Oral Tablet	PSN	b5852b90-e415-47ef-8f73-87266b58e033	4
2179635	tramadol hydrochloride 100 MG Oral Tablet	SCD	b5852b90-e415-47ef-8f73-87266b58e033	4
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	b5852b90-e415-47ef-8f73-87266b58e033	4
2179635	tramadol HCl 100 MG Oral Tablet	SY	b5852b90-e415-47ef-8f73-87266b58e033	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64980-614-01	64980061401	100 TABLET in 1 BOTTLE (64980-614-01)	100 tablet	2024-08-05	No	No	Current
64980-614-10	64980061410	1000 TABLET in 1 BOTTLE (64980-614-10)	1000 tablet	2024-08-05	No	No	Current
64980-614-50	64980061450	500 TABLET in 1 BOTTLE (64980-614-50)	500 tablet	2024-08-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride	St. Mary's Medical Park Pharmacy	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	8
Tramadol Hydrochloride	Advanced Rx of Tennessee, LLC	2026-06-26	HUMAN PRESCRIPTION DRUG LABEL	1
Tramadol Hydrochloride	Bryant Ranch Prepack	2026-06-18	HUMAN PRESCRIPTION DRUG LABEL	1
Tramadol Hydrochloride	Preferred Pharmaceuticals Inc.	2026-06-08	HUMAN PRESCRIPTION DRUG LABEL	1
Tramadol Hydrochloride	Rising Pharma Holdings, Inc. \| Graviti Pharmaceuticals Private Limited	2026-03-11	HUMAN PRESCRIPTION DRUG LABEL	4