TRAMADOL HYDROCHLORIDE

Product NDC: 71610-398
11-digit product format: 716100398
Labeler code: 71610
Product ID: 71610-398_1dff6bc2-aaf7-4003-a970-d18125b491fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAMADOL HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA091498
Marketing category: ANDA
Marketing start: 2015-05-22
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: 2021-12-31
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 · 23 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71610-398		D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-15	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-20	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-24	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-28	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-30	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-40	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-45	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-46	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-50	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-53	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-54	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-57	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-60	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-65	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-67	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-70	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-72	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-73	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-75	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-80	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-85	D	Discontinued by firm	2026-08-03
excluded package	package	71610-398	71610-398-90	D	Discontinued by firm	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 · 46 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	71610-398-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-72	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-46	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-65	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-73	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-75	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-398-70	`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	71610-398-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-72	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-67	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-46	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-65	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-73	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-75	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-398-70	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A091498-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2013-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091498-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091498-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2013-03-29	`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	A091498-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091498-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091498-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091498-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091498-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091498-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091498-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091498-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091498-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091498-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091498-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091498-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091498-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091498-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091498-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091498-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091498-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091498-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091498-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091498-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091498-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091498-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091498-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091498-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091498-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091498-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091498-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091498-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091498-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091498-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091498-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091498-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091498-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091498-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091498-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091498-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091498-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091498-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091498-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091498-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-398-15	EA - Each	71610-398	bedc0c73-e66b-4c5f-8861-cdf398eff073	1	2020-04-20
71610-398-20	EA - Each	71610-398	180dfc5c-336c-4921-afb2-b3ae1b243c8d	1	2020-04-20
71610-398-24	EA - Each	71610-398	04c290fd-4025-4f62-914b-a9df908b8494	1	2020-07-13
71610-398-28	EA - Each	71610-398	6bae0a95-9a4a-4a32-b407-13fec5a5ae2b	1	2020-04-20
71610-398-30	EA - Each	71610-398	264ef36d-a9a7-44fb-97df-9992595964e3	1	2020-04-20
71610-398-40	EA - Each	71610-398	1c130dc1-66de-429c-8c04-7f4c254b1afa	1	2020-04-20
71610-398-45	EA - Each	71610-398	4240c56a-743a-41a7-8f60-0eaaef437bca	1	2020-04-20
71610-398-46	EA - Each	71610-398	7c3aacce-24ce-4a54-a077-995a70e129ac	1	2020-04-20
71610-398-50	EA - Each	71610-398	59d5b045-3eb9-46c0-bc00-0f1da427e102	1	2020-04-20
71610-398-53	EA - Each	71610-398	1f8aafda-9f43-4065-90c8-9176f8a30308	1	2020-04-20
71610-398-54	EA - Each	71610-398	2498dc61-fa80-429e-a7b6-ee4675d549f1	1	2020-04-20
71610-398-57	EA - Each	71610-398	a5fce840-b774-4d60-bb59-b7846ab0393b	1	2020-04-20
71610-398-60	EA - Each	71610-398	9b9f8cf4-1871-4f51-a28b-adccf011b6c2	1	2020-04-20
71610-398-65	EA - Each	71610-398	99875f60-ebb0-409f-bfea-0d98d80869de	1	2020-04-20
71610-398-70	EA - Each	71610-398	568b7ce4-78c7-476b-9f4f-b6eecd1e90b2	1	2020-04-20
71610-398-72	EA - Each	71610-398	a4c219c0-d07e-462c-9ec1-871cfc082634	1	2020-04-20
71610-398-73	EA - Each	71610-398	daf67d0a-a769-4e8f-a440-570e65a15486	1	2020-04-20
71610-398-75	EA - Each	71610-398	255b0c8e-4020-407e-bba0-ee53f761fbfb	1	2020-04-20
71610-398-80	EA - Each	71610-398	68733025-0f09-45ea-b9c1-cf565998858d	1	2020-04-20
71610-398-85	EA - Each	71610-398	ddcf35e6-c2ed-4a18-99eb-3f92ed23e270	1	2020-04-20
71610-398-90	EA - Each	71610-398	ab3cbd9e-2494-4a94-a2f4-f54e8bda881b	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-398	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20200330_9c627ec3-d1fb-4d60-9adb-6a5be26f0bba.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Cranbury Pharmaceuticals, LLC	1d4af58f-17f3-4cbd-870c-098ace954872	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091498 application number: ANDA091498

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9N7R477WCK	TRAMADOL HYDROCHLORIDE	36282-47-0	TRAMADOL HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-398-15	71610039815	15 TABLET, FILM COATED in 1 BOTTLE (71610-398-15)	2020-02-21	0000-00-00	No	No	Current
71610-398-20	71610039820	20 TABLET, FILM COATED in 1 BOTTLE (71610-398-20)	2020-02-21	0000-00-00	No	No	Current
71610-398-24	71610039824	224 TABLET, FILM COATED in 1 BOTTLE (71610-398-24)	2020-02-21	0000-00-00	No	No	Current
71610-398-28	71610039828	28 TABLET, FILM COATED in 1 BOTTLE (71610-398-28)	2020-02-21	0000-00-00	No	No	Current
71610-398-30	71610039830	30 TABLET, FILM COATED in 1 BOTTLE (71610-398-30)	2020-02-21	0000-00-00	No	No	Current
71610-398-40	71610039840	40 TABLET, FILM COATED in 1 BOTTLE (71610-398-40)	2020-02-21	0000-00-00	No	No	Current
71610-398-45	71610039845	45 TABLET, FILM COATED in 1 BOTTLE (71610-398-45)	2020-02-21	0000-00-00	No	No	Current
71610-398-46	71610039846	56 TABLET, FILM COATED in 1 BOTTLE (71610-398-46)	2020-02-21	0000-00-00	No	No	Current
71610-398-50	71610039850	50 TABLET, FILM COATED in 1 BOTTLE (71610-398-50)	2020-02-21	0000-00-00	No	No	Current
71610-398-53	71610039853	60 TABLET, FILM COATED in 1 BOTTLE (71610-398-53)	2020-02-21	0000-00-00	No	No	Current
71610-398-54	71610039854	84 TABLET, FILM COATED in 1 BOTTLE (71610-398-54)	2020-02-21	0000-00-00	No	No	Current
71610-398-57	71610039857	80 TABLET, FILM COATED in 1 BOTTLE (71610-398-57)	2020-02-21	0000-00-00	No	No	Current
71610-398-60	71610039860	90 TABLET, FILM COATED in 1 BOTTLE (71610-398-60)	2020-02-21	0000-00-00	No	No	Current
71610-398-65	71610039865	100 TABLET, FILM COATED in 1 BOTTLE (71610-398-65)	2020-02-21	0000-00-00	No	No	Current
71610-398-67	71610039867	168 TABLET, FILM COATED in 1 BOTTLE (71610-398-67)	2020-02-21	0000-00-00	No	No	Current
71610-398-70	71610039870	120 TABLET, FILM COATED in 1 BOTTLE (71610-398-70)	2020-02-21	0000-00-00	No	No	Current
71610-398-72	71610039872	112 TABLET, FILM COATED in 1 BOTTLE (71610-398-72)	2020-02-21	0000-00-00	No	No	Current
71610-398-73	71610039873	135 TABLET, FILM COATED in 1 BOTTLE (71610-398-73)	2020-02-21	0000-00-00	No	No	Current
71610-398-75	71610039875	150 TABLET, FILM COATED in 1 BOTTLE (71610-398-75)	2020-02-21	0000-00-00	No	No	Current
71610-398-80	71610039880	180 TABLET, FILM COATED in 1 BOTTLE (71610-398-80)	2020-02-21	0000-00-00	No	No	Current
71610-398-85	71610039885	200 TABLET, FILM COATED in 1 BOTTLE (71610-398-85)	2020-02-21	0000-00-00	No	No	Current
71610-398-90	71610039890	240 TABLET, FILM COATED in 1 BOTTLE (71610-398-90)	2020-02-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRAMADOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	2020-03-10	HUMAN PRESCRIPTION DRUG LABEL	1