TRAMADOL HYDROCHLORIDE

Product NDC: 68180-699
11-digit product format: 681800699
Labeler code: 68180
Product ID: 68180-699_89cbc1ac-6681-42a9-b52a-0094f9b158a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAMADOL HYDROCHLORIDE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA200503
Marketing category: ANDA
Marketing start: 2014-08-19
Substance: TRAMADOL HYDROCHLORIDE
Active strength: 300 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200503-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29
A200503-002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29
A200503-003	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A200503-001	AB1
A200503-002	AB1
A200503-003	AB1

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 4 · 123 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	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL			2011-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL			2011-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		RS	2011-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL			2011-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL			2011-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200503-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200503-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2011-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200503-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2011-08-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 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	A200503-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200503-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200503-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200503-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200503-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200503-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200503-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200503-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200503-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200503-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200503-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200503-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200503-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200503-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200503-003	AB1	1	`b8a1b40f171c…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200503-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200503-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200503-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200503-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200503-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200503-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200503-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200503-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200503-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200503-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200503-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200503-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200503-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200503-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200503-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200503-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200503-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200503-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200503-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200503-002	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200503-003	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200503-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200503-002	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200503-003	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200503-001	AB1	1	`5d02ea3f76ae…`

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	300 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
833709	Internal RxNorm lookup
833711	Internal RxNorm lookup
833713	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
46bb9ae6-3ee8-463c-badb-c7a45a89b84b	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
68180-699-01	TRAMADOL HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		26
68180-699-06	TRAMADOL HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-699-06	EA - Each	68180-699	9cf196f4-042c-4949-a5b2-3df9ad10a18b	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	1
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	1
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-699	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	22	Current NDC, Legacy NDC, 2 package rows	20240117_46bb9ae6-3ee8-463c-badb-c7a45a89b84b.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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	16053b28-c759-4914-93e6-2de0afe72445	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	6bb5be12-59ff-40f4-9841-9c7ab93be2ea	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	acd5d8e0-a4cc-4654-ae04-faff347a60ca	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	b76c1366-f6c0-42ad-bb19-2b72a91490e4	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	46bb9ae6-3ee8-463c-badb-c7a45a89b84b	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503 ndc (product): 68180-699
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	83367367-5654-4078-831a-69ade48bc795	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	c30f6e9e-8014-40fc-9615-a6b8654137c1	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	A-S Medication Solutions	c28c98ac-7e07-46a5-8f34-57c008308fba	2025-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Coupler LLC	2f23ba6c-89d2-cc42-e063-6394a90aee0a	2025-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
Tramadol HCL ER	TRAMADOL HCL ER	Direct_Rx	09a7af47-423a-1e8b-e063-6394a90a99ef	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	DIRECT RX	b3c702f7-0a8c-a52b-e053-2995a90a6df3	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
Tramadol HCL ER	TRAMADOL HCL	Advanced Rx Pharmacy of Tennessee, LLC	bf51a3af-cbc6-3021-e053-2a95a90a80b7	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
Tramadol HCL ER	TRAMADOL HCL	Advanced Rx Pharmacy of Tennessee, LLC	f8c5328d-7b47-626e-e053-6294a90a04b3	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Quality Care Products, LLC	68484531-f908-473f-a422-f37234de9691	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Quality Care Products, LLC	7e421fb6-737c-49b3-b299-50511e281a4d	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
Tramadol HCL ER	TRAMADOL HCL	Advanced Rx Pharmacy of Tennessee, LLC	b4cd4b64-7db5-da44-e053-2995a90a8953	2024-11-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HCL ER	TRAMADOL HCL	DIRECT RX	5285f056-c32c-4e7a-bec6-3a726aa23d5a	2024-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	8cc09b31-6067-44ec-8aba-ea7bb1a1f448	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	b2f3f007-6dda-4532-9f7f-d93f6e65254c	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	93c9c960-afbf-6d3d-e053-2995a90a8d15	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200503 application number: ANDA200503

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
833713	traMADol HCl 300 MG 24HR Extended Release Oral Tablet	PSN	acd5d8e0-a4cc-4654-ae04-faff347a60ca	104
833713	24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet	SCD	acd5d8e0-a4cc-4654-ae04-faff347a60ca	104
833713	tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet	SY	acd5d8e0-a4cc-4654-ae04-faff347a60ca	104
833709	traMADol HCl 100 MG 24HR Extended Release Oral Tablet	PSN	46bb9ae6-3ee8-463c-badb-c7a45a89b84b	26
833711	traMADol HCl 200 MG 24HR Extended Release Oral Tablet	PSN	46bb9ae6-3ee8-463c-badb-c7a45a89b84b	26
833713	traMADol HCl 300 MG 24HR Extended Release Oral Tablet	PSN	46bb9ae6-3ee8-463c-badb-c7a45a89b84b	26
833709	24 HR tramadol hydrochloride 100 MG Extended Release Oral Tablet	SCD	46bb9ae6-3ee8-463c-badb-c7a45a89b84b	26
833711	24 HR tramadol hydrochloride 200 MG Extended Release Oral Tablet	SCD	46bb9ae6-3ee8-463c-badb-c7a45a89b84b	26
833713	24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet	SCD	46bb9ae6-3ee8-463c-badb-c7a45a89b84b	26
833711	tramadol HCl 200 MG 24 HR Extended Release Oral Tablet	SY	46bb9ae6-3ee8-463c-badb-c7a45a89b84b	26
833709	tramadol hydrochloride 100 MG 24 HR Extended Release Oral Tablet	SY	46bb9ae6-3ee8-463c-badb-c7a45a89b84b	26
833713	tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet	SY	46bb9ae6-3ee8-463c-badb-c7a45a89b84b	26
833713	traMADol HCl 300 MG 24HR Extended Release Oral Tablet	PSN	b76c1366-f6c0-42ad-bb19-2b72a91490e4	13
833713	24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet	SCD	b76c1366-f6c0-42ad-bb19-2b72a91490e4	13
833713	tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet	SY	b76c1366-f6c0-42ad-bb19-2b72a91490e4	13
833713	traMADol HCl 300 MG 24HR Extended Release Oral Tablet	PSN	93e129c8-64c4-1f6d-e053-2a95a90ac1f8	3
833713	24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet	SCD	93e129c8-64c4-1f6d-e053-2a95a90ac1f8	3
833713	tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet	SY	93e129c8-64c4-1f6d-e053-2a95a90ac1f8	3
833713	traMADol HCl 300 MG 24HR Extended Release Oral Tablet	PSN	3c187736-ea96-4e59-9fe6-cb625a619c63	2
833713	traMADol HCl 300 MG 24HR Extended Release Oral Tablet	PSN	f8c5328d-7b47-626e-e053-6294a90a04b3	2
833713	traMADol HCl 300 MG 24HR Extended Release Oral Tablet	PSN	09a7af47-423a-1e8b-e063-6394a90a99ef	2
833713	24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet	SCD	3c187736-ea96-4e59-9fe6-cb625a619c63	2
833713	24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet	SCD	f8c5328d-7b47-626e-e053-6294a90a04b3	2
833713	24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet	SCD	09a7af47-423a-1e8b-e063-6394a90a99ef	2
833713	tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet	SY	09a7af47-423a-1e8b-e063-6394a90a99ef	2
833713	tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet	SY	f8c5328d-7b47-626e-e053-6294a90a04b3	2
833713	tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet	SY	3c187736-ea96-4e59-9fe6-cb625a619c63	2
833709	traMADol HCl 100 MG 24HR Extended Release Oral Tablet	PSN	a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc	1
833711	traMADol HCl 200 MG 24HR Extended Release Oral Tablet	PSN	a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc	1
833713	traMADol HCl 300 MG 24HR Extended Release Oral Tablet	PSN	a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc	1
833713	traMADol HCl 300 MG 24HR Extended Release Oral Tablet	PSN	b8cb8f4c-fa6a-b603-e053-2a95a90aa3bb	1
833713	traMADol HCl 300 MG 24HR Extended Release Oral Tablet	PSN	1278980b-4068-df57-e063-6394a90a8742	1
833709	24 HR tramadol hydrochloride 100 MG Extended Release Oral Tablet	SCD	a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc	1
833711	24 HR tramadol hydrochloride 200 MG Extended Release Oral Tablet	SCD	a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc	1
833713	24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet	SCD	a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc	1
833713	24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet	SCD	b8cb8f4c-fa6a-b603-e053-2a95a90aa3bb	1
833713	24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet	SCD	1278980b-4068-df57-e063-6394a90a8742	1
833711	tramadol HCl 200 MG 24 HR Extended Release Oral Tablet	SY	a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc	1
833709	tramadol hydrochloride 100 MG 24 HR Extended Release Oral Tablet	SY	a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc	1
833713	tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet	SY	a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc	1
833713	tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet	SY	b8cb8f4c-fa6a-b603-e053-2a95a90aa3bb	1
833713	tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet	SY	1278980b-4068-df57-e063-6394a90a8742	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-699-01	68180069901	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-699-01)	2014-08-19	0000-00-00	No	No	Current
68180-699-06	68180069906	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-699-06)	2014-08-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	2026-04-13	HUMAN PRESCRIPTION DRUG LABEL	104
TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	13
TRAMADOL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	26
Tramadol HCL ER C-IV	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Tramadol HCL ER Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2
TRAMADOL HYDROCHLORIDE	Quality Care Products, LLC	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	3
TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	3
TRAMADOL HYDROCHLORIDE	Medsource Pharmaceuticals \| LUPIN LIMITED	2024-02-28	HUMAN PRESCRIPTION DRUG LABEL	1
TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-02-15	HUMAN PRESCRIPTION DRUG LABEL	1
TRAMADOL HYDROCHLORIDE	Proficient Rx LP	2022-07-01	HUMAN PRESCRIPTION DRUG LABEL	2
TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	2021-01-13	HUMAN PRESCRIPTION DRUG LABEL	1