ULTRAM ER

Product NDC: 21695-563
11-digit product format: 216950563
Labeler code: 21695
Product ID: 21695-563_2fd193e2-7aa7-4119-b540-7e28e82fbd13
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tramadol hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA021692
Marketing category: NDA
Marketing start: 2005-09-08
Marketing end: 0000-00-00
Substance: TRAMADOL HYDROCHLORIDE
Active strength: 200 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-563		I	Inactivated by FDA		2026-08-03
excluded package	package	21695-563	21695-563-30	I	Inactivated by FDA		2026-08-03

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-563-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-563-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-563-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-563-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-563-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-563-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-563-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-563-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-563-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-563-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-563-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-563-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-563-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-563-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-563-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-563-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-563-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-563-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-563-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-563-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-563-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-563-30	`110d247fa046…`	`a55b01930146…`

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	RLD / RS	Approval date
N021692-001	ULTRAM ER	TRAMADOL HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08
N021692-002	ULTRAM ER	TRAMADOL HYDROCHLORIDE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08
N021692-003	ULTRAM ER	TRAMADOL HYDROCHLORIDE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021692-001	ULTRAM ER	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021692-002	ULTRAM ER	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021692-003	ULTRAM ER	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021692-001	ULTRAM ER	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021692-002	ULTRAM ER	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021692-003	ULTRAM ER	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021692-001	ULTRAM ER	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021692-002	ULTRAM ER	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021692-003	ULTRAM ER	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021692-001	ULTRAM ER	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021692-002	ULTRAM ER	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021692-003	ULTRAM ER	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021692-001	ULTRAM ER	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021692-002	ULTRAM ER	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021692-003	ULTRAM ER	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021692-001	ULTRAM ER	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021692-002	ULTRAM ER	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021692-003	ULTRAM ER	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021692-001	ULTRAM ER	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021692-002	ULTRAM ER	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021692-003	ULTRAM ER	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021692-001	ULTRAM ER	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021692-002	ULTRAM ER	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021692-003	ULTRAM ER	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021692-001	ULTRAM ER	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021692-002	ULTRAM ER	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021692-003	ULTRAM ER	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021692-001	ULTRAM ER	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021692-002	ULTRAM ER	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021692-003	ULTRAM ER	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021692-001	ULTRAM ER	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021692-002	ULTRAM ER	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021692-003	ULTRAM ER	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021692-001	ULTRAM ER	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021692-002	ULTRAM ER	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021692-003	ULTRAM ER	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021692-001	ULTRAM ER	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021692-002	ULTRAM ER	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021692-003	ULTRAM ER	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021692-001	ULTRAM ER	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2005-09-08	`8072bd15b7f6…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-563-30	2019-09-24	C162847	48780-1	934fe258-4a25-48b1-e053-8cdaa90a720a	ULTRAM ® ER (tramadol HCl) Extended-Release Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-563-30	ULTRAM ER	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-563-30	EA - Each	21695-563	22257d86-28ad-4751-892c-6cd52ee88749	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
tramadol hydrochloride	ACTIVE INGREDIENT	9N7R477WCK	ULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
tramadol	ACTIVE MOIETY	39J1LGJ30J	ULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
1-VINYL-2-PYRROLIDONE	INACTIVE INGREDIENT	76H9G81541	ULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
dibutyl sebacate	INACTIVE INGREDIENT	4W5IH7FLNY	ULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	ULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	ULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-563	ULTRAM ER (TRAMADOL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20101210_2fd193e2-7aa7-4119-b540-7e28e82fbd13.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
833709	traMADol HCl 100 MG 24HR Extended Release Oral Tablet	PSN	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
833711	traMADol HCl 200 MG 24HR Extended Release Oral Tablet	PSN	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
833713	traMADol HCl 300 MG 24HR Extended Release Oral Tablet	PSN	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
845314	Ultram ER 100 MG 24HR Extended Release Oral Tablet	PSN	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
845315	Ultram ER 200 MG 24HR Extended Release Oral Tablet	PSN	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
845316	Ultram ER 300 MG 24HR Extended Release Oral Tablet	PSN	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
845314	24 HR tramadol hydrochloride 100 MG Extended Release Oral Tablet [Ultram]	SBD	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
845315	24 HR tramadol hydrochloride 200 MG Extended Release Oral Tablet [Ultram]	SBD	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
845316	24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet [Ultram]	SBD	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
833709	24 HR tramadol hydrochloride 100 MG Extended Release Oral Tablet	SCD	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
833711	24 HR tramadol hydrochloride 200 MG Extended Release Oral Tablet	SCD	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
833713	24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet	SCD	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
845314	24 HR Ultram 100 MG Extended Release Oral Tablet	SY	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
845315	24 HR Ultram 200 MG Extended Release Oral Tablet	SY	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
845316	24 HR Ultram 300 MG Extended Release Oral Tablet	SY	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
833711	tramadol HCl 200 MG 24 HR Extended Release Oral Tablet	SY	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
833709	tramadol hydrochloride 100 MG 24 HR Extended Release Oral Tablet	SY	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
833713	tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet	SY	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
845314	Ultram ER 100 MG 24 HR Extended Release Oral Tablet	SY	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
845315	Ultram ER 200 MG 24 HR Extended Release Oral Tablet	SY	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1
845316	Ultram ER 300 MG 24 HR Extended Release Oral Tablet	SY	2fd193e2-7aa7-4119-b540-7e28e82fbd13	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-563-30	21695056330	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ULTRAM ® ER (tramadol HCl) Extended-Release Tablets	Rebel Distributors Corp	2010-12-01	HUMAN PRESCRIPTION DRUG LABEL	1