tramadol hydrochloride

Product NDC: 57664-377
Requested package NDC: 57664-377-18
11-digit product format: 576640377
Labeler code: 57664
Product ID: 57664-377_ec6ca108-bbe1-46af-e053-2995a90a04c6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tramadol hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA075964
Marketing category: ANDA
Marketing start: 2002-06-22
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	57664-377	57664-377-18	D	Discontinued by firm		2026-08-07

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 · 1 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	57664-377	57664-377-18	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A075964-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075964-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-06-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075964-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075964-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075964-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075964-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075964-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075964-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075964-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075964-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075964-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075964-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075964-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075964-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075964-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075964-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075964-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075964-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075964-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075964-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075964-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075964-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075964-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075964-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075964-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075964-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075964-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075964-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075964-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075964-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075964-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075964-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075964-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075964-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075964-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075964-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075964-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075964-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075964-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075964-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075964-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075964-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075964-001	AB	1	`cb3db0bc1861…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-377-08	EA - Each	57664-377	42e2d73b-53b7-44a5-9f4e-ddf8afdef3f2	1	2012-07-24
57664-377-13	EA - Each	57664-377	709c10be-ee1d-4429-a568-c64651c92fe5	1	2012-07-24
57664-377-18	EA - Each	57664-377	0363607a-e255-4c1f-a824-e6ee6951eb43	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	12
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	12
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	12
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	12
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	12
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	12
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET [DIRECT RX]	3
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]	3
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET [DIRECT RX]	3
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAMADOL HYDROCHLORIDE TABLET [DIRECT RX]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET [DIRECT RX]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET [DIRECT RX]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE TABLET [DIRECT RX]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE TABLET [DIRECT RX]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET [DIRECT RX]	3
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAMADOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY ]	1
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY ]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRAMADOL HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY ]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY ]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY ]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY ]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY ]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY ]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY ]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57664-377	TRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	28	Legacy NDC	20250114_cabccc8a-6f9f-414c-93f0-6dec331ed74b.zip

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	908cfd1e-d668-59c0-e053-2a95a90a92c2	9
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	908cfd1e-d668-59c0-e053-2a95a90a92c2	9
835603	traMADol HCl 50 MG Oral Tablet	PSN	71118582-d521-4003-b18b-a7bf82c3d286	8
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	71118582-d521-4003-b18b-a7bf82c3d286	8
835603	traMADol HCl 50 MG Oral Tablet	PSN	f4ae0017-5050-4b92-9944-340385152b95	7
835603	traMADol HCl 50 MG Oral Tablet	PSN	a0ad984a-38da-1fe0-e053-2995a90af23e	7
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	a0ad984a-38da-1fe0-e053-2995a90af23e	7
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	f4ae0017-5050-4b92-9944-340385152b95	7
835603	traMADol HCl 50 MG Oral Tablet	PSN	4e2c0893-6faf-15ed-e054-00144ff8d46c	5
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	4e2c0893-6faf-15ed-e054-00144ff8d46c	5
835603	traMADol HCl 50 MG Oral Tablet	PSN	9ba9c68c-ff27-eb24-e053-2a95a90ae21c	4
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	9ba9c68c-ff27-eb24-e053-2a95a90ae21c	4
835603	traMADol HCl 50 MG Oral Tablet	PSN	42624fb5-5518-4fae-bf40-5ba69e16240b	3
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	42624fb5-5518-4fae-bf40-5ba69e16240b	3
835603	traMADol HCl 50 MG Oral Tablet	PSN	b3e15b56-45eb-979c-e053-2a95a90a14b1	1
835603	traMADol HCl 50 MG Oral Tablet	PSN	38da58e9-79a6-447d-a07c-0f0084fb03ff	1
835603	traMADol HCl 50 MG Oral Tablet	PSN	dd5387d7-17c3-4949-978a-3ca5578364c1	1
835603	traMADol HCl 50 MG Oral Tablet	PSN	d5576a76-b16c-4db2-a762-c03194b1e44c	1
835603	traMADol HCl 50 MG Oral Tablet	PSN	b533007a-ffe8-4de7-e053-2a95a90a1901	1
835603	traMADol HCl 50 MG Oral Tablet	PSN	a9cbcaf6-9312-7f66-e053-2995a90ad12d	1
835603	traMADol HCl 50 MG Oral Tablet	PSN	592cc647-c395-3e30-e053-2991aa0a506d	1
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	b3e15b56-45eb-979c-e053-2a95a90a14b1	1
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	592cc647-c395-3e30-e053-2991aa0a506d	1
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	b533007a-ffe8-4de7-e053-2a95a90a1901	1
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	d5576a76-b16c-4db2-a762-c03194b1e44c	1
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	dd5387d7-17c3-4949-978a-3ca5578364c1	1
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	a9cbcaf6-9312-7f66-e053-2995a90ad12d	1
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	38da58e9-79a6-447d-a07c-0f0084fb03ff	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57664-377-18	57664037718	1000 TABLET in 1 BOTTLE (57664-377-18)	1000 tablet	2002-06-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
tramadol hydrochloride	Bryant Ranch Prepack	2025-04-02	HUMAN PRESCRIPTION DRUG LABEL	102
tramadol hydrochloride	A-S Medication Solutions	2025-04-02	HUMAN PRESCRIPTION DRUG LABEL	21
tramadol hydrochloride	A-S Medication Solutions	2025-04-02	HUMAN PRESCRIPTION DRUG LABEL	19
tramadol hydrochloride	Bryant Ranch Prepack	2025-03-31	HUMAN PRESCRIPTION DRUG LABEL	6
tramadol hydrochloride	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2025-01-13	HUMAN PRESCRIPTION DRUG LABEL	28
Tramadol HCL Tablet	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	7
tramadol hydrochloride	Major Pharmaceuticals	2024-10-30	HUMAN PRESCRIPTION DRUG LABEL	3
tramadol hydrochloride	REMEDYREPACK INC.	2024-09-26	HUMAN PRESCRIPTION DRUG LABEL	23
tramadol hydrochloride	REMEDYREPACK INC.	2024-09-04	HUMAN PRESCRIPTION DRUG LABEL	17
tramadol hydrochloride	Bryant Ranch Prepack	2024-08-20	HUMAN PRESCRIPTION DRUG LABEL	11
tramadol 50mg	RedPharm Drug, Inc. \| EPM Packaging, Inc.	2024-07-11	HUMAN PRESCRIPTION DRUG LABEL	5
tramadol hydrochloride	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	7
tramadol hydrochloride	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	4
Tramadol HCL 50mg Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-05-30	HUMAN PRESCRIPTION DRUG LABEL	11
tramadol hydrochloride	Clinical Solutions Wholesale, LLC	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	3
Tramadol Hydrochloride Tablets, USP, CIV 50 mg - Rx only	St. Mary's Medical Park Pharmacy	2023-12-08	HUMAN PRESCRIPTION DRUG LABEL	9
tramadol hydrochloride	Preferred Pharmaceuticals Inc.	2023-10-03	HUMAN PRESCRIPTION DRUG LABEL	5
tramadol hydrochloride	Proficient Rx LP	2023-08-01	HUMAN PRESCRIPTION DRUG LABEL	6
TRAMADOL HYDROCHLORIDE	Direct_Rx	2023-04-17	HUMAN PRESCRIPTION DRUG LABEL	9
tramadol hydrochloride	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-04-14	HUMAN PRESCRIPTION DRUG LABEL	4
tramadol hydrochloride	Northwind Pharmaceuticals, LLC \| EPM Packaging	2023-03-31	HUMAN PRESCRIPTION DRUG LABEL	1
tramadol hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
TRAMADOL HYDROCHLORIDE	Direct Rx	2022-09-30	HUMAN PRESCRIPTION DRUG LABEL	7
tramadol hydrochloride	Quality Care Products, LLC	2022-06-08	HUMAN PRESCRIPTION DRUG LABEL	4
tramadol hydrochloride	RPK Pharmaceuticals, Inc.	2022-03-30	HUMAN PRESCRIPTION DRUG LABEL	1