Tramadol HCL

Product NDC: 80425-0127
11-digit product format: 804250127
Labeler code: 80425
Product ID: 80425-0127_2a99a7c1-c4ba-2b01-e063-6294a90aa3b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol HCL
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA091607
Marketing category: ANDA
Marketing start: 2011-12-30
Substance: TRAMADOL HYDROCHLORIDE
Active strength: 200 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

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 · 3 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	Archive	Snapshot	Source SHA-256
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	80425-0127		E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	80425-0127	80425-0127-2	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	80425-0127	80425-0127-1	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`

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
A091607-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-30
A091607-002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-30
A091607-003	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-30

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	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	RS	2011-12-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091607-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091607-002	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091607-003	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091607-001	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091607-002	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091607-003	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091607-001	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091607-002	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091607-003	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091607-001	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091607-002	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091607-003	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091607-001	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091607-002	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091607-003	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091607-001	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091607-002	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091607-003	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091607-001	AB2	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091607-002	AB2	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091607-003	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091607-001	AB2	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091607-002	AB2	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091607-003	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091607-001	AB2	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091607-002	AB2	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091607-003	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091607-001	AB2	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091607-002	AB2	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091607-003	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091607-001	AB2	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091607-002	AB2	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091607-003	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091607-001	AB2	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091607-002	AB2	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091607-003	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091607-001	AB2	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091607-002	AB2	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091607-003	AB2	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091607-001	AB2	1	`a67488948f0b…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tramadol HCL
Brand name suffix: ER
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRAMADOL HYDROCHLORIDE	200 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1946527	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
bba287fe-fbf6-65a9-e053-2a95a90a9237	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
80425-0127-1	Tramadol HCLER	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		6
80425-0127-2	Tramadol HCLER	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0127-1	EA - Each	80425-0127	41f3ca04-56ba-48c6-a5c2-edc94654d6ee	1	2023-03-13
80425-0127-2	EA - Each	80425-0127	1fb9eed3-5f2c-4443-b67e-ff4a2732eae2	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0127	TRAMADOL HCL ER (TRAMADOL HCL) TABLET, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20250101_bba287fe-fbf6-65a9-e053-2a95a90a9237.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	dc420d50-6192-482d-b3da-3be55870a79a	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091607 application number: ANDA091607
Tramadol HCL ER	TRAMADOL HCL	Advanced Rx Pharmacy of Tennessee, LLC	bba287fe-fbf6-65a9-e053-2a95a90a9237	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091607 application number: ANDA091607 ndc (product): 80425-0127

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
1946527	traMADol hydrochloride 200 MG Matrix Delivery 24HR Extended Release Oral Tablet	PSN	bba287fe-fbf6-65a9-e053-2a95a90a9237	6
1946527	Matrix Delivery 24 HR tramadol hydrochloride 200 MG Extended Release Oral Tablet	SCD	bba287fe-fbf6-65a9-e053-2a95a90a9237	6
1946527	tramadol hydrochloride 200 MG Matrix Delivery 24 HR Extended Release Oral Tablet	SY	bba287fe-fbf6-65a9-e053-2a95a90a9237	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
80425-0127-1	80425012701	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0127-1)	2011-12-30	0000-00-00	No	No	Current
80425-0127-2	80425012702	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0127-2)	2011-12-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol HCL ER Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	6