tramadol hydrochloride

Product NDC: 50436-0377
11-digit product format: 504360377
Labeler code: 50436
Product ID: 50436-0377_68be38f8-e815-4448-895b-e4568b7fc97e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tramadol hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Unit Dose Services
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: 2020-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50436-0377		I	Inactivated by FDA	2026-08-03
excluded package	package	50436-0377	50436-0377-1	I	Inactivated by FDA	2026-08-03
excluded package	package	50436-0377	50436-0377-2	I	Inactivated by FDA	2026-08-03
excluded package	package	50436-0377	50436-0377-3	I	Inactivated by FDA	2026-08-03
excluded package	package	50436-0377	50436-0377-4	I	Inactivated by FDA	2026-08-03
excluded package	package	50436-0377	50436-0377-5	I	Inactivated by FDA	2026-08-03
excluded package	package	50436-0377	50436-0377-6	I	Inactivated by FDA	2026-08-03
excluded package	package	50436-0377	50436-0377-7	I	Inactivated by FDA	2026-08-03
excluded package	package	50436-0377	50436-0377-8	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 3 · 171 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	50436-0377-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-0377-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-0377-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-0377-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-0377-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-0377-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-0377-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-0377-7	`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	50436-0377-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-0377-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-0377-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-0377-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-0377-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-0377-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-0377-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-0377-7	`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	50436-0377-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-0377-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-0377-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-0377-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-0377-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-0377-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-0377-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-0377-7	`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	50436-0377-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-0377-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-0377-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-0377-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-0377-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-0377-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-0377-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-0377-7	`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	50436-0377-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-0377-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-0377-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-0377-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-0377-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-0377-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-0377-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-0377-7	`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	50436-0377-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-0377-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-0377-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-0377-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-0377-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-0377-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-0377-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-0377-7	`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	50436-0377-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-0377-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-0377-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-0377-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-0377-4	`302b2466d912…`	`e7b80fea0513…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
50436-0377-1	Tramadol Hydrochloride Tablets, USP, CIV
50436-0377-2	Tramadol Hydrochloride Tablets, USP, CIV
50436-0377-3	Tramadol Hydrochloride Tablets, USP, CIV
50436-0377-4	Tramadol Hydrochloride Tablets, USP, CIV
50436-0377-5	Tramadol Hydrochloride Tablets, USP, CIV
50436-0377-6	Tramadol Hydrochloride Tablets, USP, CIV
50436-0377-7	Tramadol Hydrochloride Tablets, USP, CIV
50436-0377-8	Tramadol Hydrochloride Tablets, USP, CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50436-0377-1	tramadol hydrochloride	30 in 1 BOTTLE	TABLET	30	8
50436-0377-2	tramadol hydrochloride	60 in 1 BOTTLE	TABLET	60	8
50436-0377-3	tramadol hydrochloride	90 in 1 BOTTLE	TABLET	90	8
50436-0377-4	tramadol hydrochloride	50 in 1 BOTTLE	TABLET	50	8
50436-0377-5	tramadol hydrochloride	120 in 1 BOTTLE	TABLET	120	8
50436-0377-6	tramadol hydrochloride	180 in 1 BOTTLE	TABLET	180	8
50436-0377-7	tramadol hydrochloride	240 in 1 BOTTLE	TABLET	240	8
50436-0377-8	tramadol hydrochloride	15 in 1 BOTTLE	TABLET	15	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-0377-8	EA - Each	50436-0377	fedd60db-23e6-4dc0-9a78-8f1df33988ac	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-0377	TRAMADOL HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	8	Legacy NDC, 8 package rows	20180717_71118582-d521-4003-b18b-a7bf82c3d286.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	71118582-d521-4003-b18b-a7bf82c3d286	8
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	71118582-d521-4003-b18b-a7bf82c3d286	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-0377-1	50436037701	30 in 1 BOTTLE	Historical
50436-0377-2	50436037702	60 in 1 BOTTLE	Historical
50436-0377-3	50436037703	90 in 1 BOTTLE	Historical
50436-0377-4	50436037704	50 in 1 BOTTLE	Historical
50436-0377-5	50436037705	120 in 1 BOTTLE	Historical
50436-0377-6	50436037706	180 in 1 BOTTLE	Historical
50436-0377-7	50436037707	240 in 1 BOTTLE	Historical
50436-0377-8	50436037708	15 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride Tablets, USP, CIV	Unit Dose Services	2018-07-17	HUMAN PRESCRIPTION DRUG LABEL	8