TRAMADOL HYDROCHLORIDE

Product NDC: 47335-861
11-digit product format: 473350861
Labeler code: 47335
Product ID: 47335-861_a994e116-d201-47f9-baaf-dd76a84eba7e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAMADOL HYDROCHLORIDE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA201384
Marketing category: ANDA
Marketing start: 2011-12-12
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: 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A201384-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-07
A201384-002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-07
A201384-003	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-07

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201384-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2011-12-07	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201384-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201384-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201384-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201384-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201384-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201384-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201384-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201384-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201384-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201384-002	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201384-003	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201384-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201384-002	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201384-003	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201384-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201384-002	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201384-003	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201384-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201384-002	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201384-003	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201384-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201384-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201384-003	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201384-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201384-002	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201384-003	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201384-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201384-002	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201384-003	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201384-001	AB1	1	`87673890dc5c…`

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	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
004de5a4-80f8-4040-a6ea-be5e99352a36	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	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
47335-861-08	TRAMADOL HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	24
47335-861-18	TRAMADOL HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	24
47335-861-83	TRAMADOL HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	24
47335-861-88	TRAMADOL HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-861-83	EA - Each	47335-861	32a964cf-d4be-4115-88a3-478662c15ce1	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, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-861	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	21	Current NDC, Legacy NDC, 4 package rows	20231213_004de5a4-80f8-4040-a6ea-be5e99352a36.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	66359f41-9999-4cb8-b632-1fe2ec1e60b2	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	43fe10b2-17a4-4dc2-9a48-2378547b61fd	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	a77b0dba-8ac7-418a-b435-16a0e6c22804	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	004de5a4-80f8-4040-a6ea-be5e99352a36	2025-11-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384 ndc (product): 47335-861
Tramadol HCL ER	TRAMADOL HCL	Advanced Rx Pharmacy of Tennessee, LLC	c197f4e4-9ea5-562b-e053-2a95a90a975c	2024-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384
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): 201384 application number: ANDA201384
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	00b7f61b-5173-43e6-a3f9-d2efbda40c19	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	dce0d21e-e4c2-4875-a2ce-9d53df190b80	2022-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	27495d02-8641-4c92-b5a3-edf50abc2a6f	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	68646295-49b2-45ac-bf19-99bb91f7333d	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201384 application number: ANDA201384

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	a77b0dba-8ac7-418a-b435-16a0e6c22804	1006
833713	24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet	SCD	a77b0dba-8ac7-418a-b435-16a0e6c22804	1006
833713	tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet	SY	a77b0dba-8ac7-418a-b435-16a0e6c22804	1006
833709	traMADol HCl 100 MG 24HR Extended Release Oral Tablet	PSN	004de5a4-80f8-4040-a6ea-be5e99352a36	24
833711	traMADol HCl 200 MG 24HR Extended Release Oral Tablet	PSN	004de5a4-80f8-4040-a6ea-be5e99352a36	24
833713	traMADol HCl 300 MG 24HR Extended Release Oral Tablet	PSN	004de5a4-80f8-4040-a6ea-be5e99352a36	24
833709	24 HR tramadol hydrochloride 100 MG Extended Release Oral Tablet	SCD	004de5a4-80f8-4040-a6ea-be5e99352a36	24
833711	24 HR tramadol hydrochloride 200 MG Extended Release Oral Tablet	SCD	004de5a4-80f8-4040-a6ea-be5e99352a36	24
833713	24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet	SCD	004de5a4-80f8-4040-a6ea-be5e99352a36	24
833711	tramadol HCl 200 MG 24 HR Extended Release Oral Tablet	SY	004de5a4-80f8-4040-a6ea-be5e99352a36	24
833709	tramadol hydrochloride 100 MG 24 HR Extended Release Oral Tablet	SY	004de5a4-80f8-4040-a6ea-be5e99352a36	24
833713	tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet	SY	004de5a4-80f8-4040-a6ea-be5e99352a36	24
833709	traMADol HCl 100 MG 24HR Extended Release Oral Tablet	PSN	dce0d21e-e4c2-4875-a2ce-9d53df190b80	1
833711	traMADol HCl 200 MG 24HR Extended Release Oral Tablet	PSN	dce0d21e-e4c2-4875-a2ce-9d53df190b80	1
833713	traMADol HCl 300 MG 24HR Extended Release Oral Tablet	PSN	dce0d21e-e4c2-4875-a2ce-9d53df190b80	1
833713	traMADol HCl 300 MG 24HR Extended Release Oral Tablet	PSN	dfd9ef75-e360-40f5-e053-2995a90a4be7	1
833713	traMADol HCl 300 MG 24HR Extended Release Oral Tablet	PSN	68646295-49b2-45ac-bf19-99bb91f7333d	1
833709	24 HR tramadol hydrochloride 100 MG Extended Release Oral Tablet	SCD	dce0d21e-e4c2-4875-a2ce-9d53df190b80	1
833711	24 HR tramadol hydrochloride 200 MG Extended Release Oral Tablet	SCD	dce0d21e-e4c2-4875-a2ce-9d53df190b80	1
833713	24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet	SCD	dce0d21e-e4c2-4875-a2ce-9d53df190b80	1
833713	24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet	SCD	68646295-49b2-45ac-bf19-99bb91f7333d	1
833713	24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet	SCD	dfd9ef75-e360-40f5-e053-2995a90a4be7	1
833711	tramadol HCl 200 MG 24 HR Extended Release Oral Tablet	SY	dce0d21e-e4c2-4875-a2ce-9d53df190b80	1
833709	tramadol hydrochloride 100 MG 24 HR Extended Release Oral Tablet	SY	dce0d21e-e4c2-4875-a2ce-9d53df190b80	1
833713	tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet	SY	68646295-49b2-45ac-bf19-99bb91f7333d	1
833713	tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet	SY	dce0d21e-e4c2-4875-a2ce-9d53df190b80	1
833713	tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet	SY	dfd9ef75-e360-40f5-e053-2995a90a4be7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-861-08	47335086108	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-861-08)	2011-12-12	0000-00-00	No	No	Current
47335-861-18	47335086118	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-861-18)	2011-12-12	0000-00-00	No	No	Current
47335-861-83	47335086183	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-861-83)	2011-12-12	0000-00-00	No	No	Current
47335-861-88	47335086188	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-861-88)	2011-12-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRAMADOL HYDROCHLORIDE	Bryant Ranch Prepack	2026-04-07	HUMAN PRESCRIPTION DRUG LABEL	1006
TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2025-11-20	Human Prescription Drug Label	24
TRAMADOL HYDROCHLORIDE	REMEDYREPACK INC.	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	3
Tramadol Hydrochloride Extended-Release Tablets	Lake Erie Medical DBA Quality Care Products LLC	2022-08-17	HUMAN PRESCRIPTION DRUG LABEL	4
TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-07-25	HUMAN PRESCRIPTION DRUG LABEL	1
TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	2022-05-25	HUMAN PRESCRIPTION DRUG LABEL	1
TRAMADOL HYDROCHLORIDE	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	1