Tramadol Hydrochloride

Product NDC: 71610-865
Requested package NDC: 71610-865-80
11-digit product format: 716100865
Labeler code: 71610
Product ID: 71610-865_27460b14-190b-94e9-e063-6394a90ae97f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA075977
Marketing category: ANDA
Marketing start: 2002-06-19
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075977-001	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
A075977-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075977-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-19	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075977-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075977-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075977-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075977-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075977-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075977-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075977-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075977-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075977-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075977-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075977-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075977-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075977-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075977-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075977-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075977-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075977-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075977-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075977-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075977-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075977-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075977-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075977-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075977-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075977-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075977-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075977-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075977-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075977-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075977-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075977-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075977-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075977-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075977-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075977-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075977-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075977-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075977-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075977-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075977-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	50 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
835603	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
27460cc6-0782-7838-e063-6394a90a19f1	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	SPL version
71610-865-15	Tramadol Hydrochloride	15 in 1 BOTTLE	TABLET, FILM COATED	15	1
71610-865-20	Tramadol Hydrochloride	20 in 1 BOTTLE	TABLET, FILM COATED	20	1
71610-865-24	Tramadol Hydrochloride	224 in 1 BOTTLE	TABLET, FILM COATED	224	1
71610-865-28	Tramadol Hydrochloride	28 in 1 BOTTLE	TABLET, FILM COATED	28	1
71610-865-30	Tramadol Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
71610-865-40	Tramadol Hydrochloride	40 in 1 BOTTLE	TABLET, FILM COATED	40	1
71610-865-45	Tramadol Hydrochloride	45 in 1 BOTTLE	TABLET, FILM COATED	45	1
71610-865-46	Tramadol Hydrochloride	56 in 1 BOTTLE	TABLET, FILM COATED	56	1
71610-865-50	Tramadol Hydrochloride	50 in 1 BOTTLE	TABLET, FILM COATED	50	1
71610-865-53	Tramadol Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	1
71610-865-54	Tramadol Hydrochloride	84 in 1 BOTTLE	TABLET, FILM COATED	84	1
71610-865-57	Tramadol Hydrochloride	80 in 1 BOTTLE	TABLET, FILM COATED	80	1
71610-865-60	Tramadol Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	1
71610-865-65	Tramadol Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	1
71610-865-67	Tramadol Hydrochloride	168 in 1 BOTTLE	TABLET, FILM COATED	168	1
71610-865-70	Tramadol Hydrochloride	120 in 1 BOTTLE	TABLET, FILM COATED	120	1
71610-865-72	Tramadol Hydrochloride	112 in 1 BOTTLE	TABLET, FILM COATED	112	1
71610-865-73	Tramadol Hydrochloride	135 in 1 BOTTLE	TABLET, FILM COATED	135	1
71610-865-75	Tramadol Hydrochloride	150 in 1 BOTTLE	TABLET, FILM COATED	150	1
71610-865-80	Tramadol Hydrochloride	180 in 1 BOTTLE	TABLET, FILM COATED	180	1
71610-865-85	Tramadol Hydrochloride	200 in 1 BOTTLE	TABLET, FILM COATED	200	1
71610-865-90	Tramadol Hydrochloride	240 in 1 BOTTLE	TABLET, FILM COATED	240	1
71610-865-92	Tramadol Hydrochloride	270 in 1 BOTTLE	TABLET, FILM COATED	270	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-865-15	EA - Each	71610-865	3133a2da-187e-4e87-beb9-02806c211978	1	2025-02-10
71610-865-20	EA - Each	71610-865	3331e117-21ec-47d2-b8fb-4bc23b7982c8	1	2025-02-10
71610-865-24	EA - Each	71610-865	0d74ad36-be17-4397-aead-c51859e66c3d	1	2025-02-10
71610-865-28	EA - Each	71610-865	f0adecc6-ce43-49a9-8e66-508909a2d240	1	2025-02-10
71610-865-30	EA - Each	71610-865	e422f323-1a50-4c34-9f88-50b002a3b0e8	1	2025-02-10
71610-865-40	EA - Each	71610-865	bdea639b-4cc0-43a4-bdcc-e49af33ee977	1	2025-02-10
71610-865-45	EA - Each	71610-865	aa461f9f-b296-4aac-bb87-3cb05634630f	1	2025-02-10
71610-865-46	EA - Each	71610-865	2ea31b8d-d26e-438f-b87b-df090aa30377	1	2025-02-10
71610-865-50	EA - Each	71610-865	7ce1b5c4-64d1-4335-b656-c850f86c203f	1	2025-02-10
71610-865-53	EA - Each	71610-865	87e20986-ea15-4fda-b7fb-2f404461acd7	1	2025-02-10
71610-865-54	EA - Each	71610-865	f11f0ec5-9b57-4118-9065-c5d559120f99	1	2025-02-10
71610-865-57	EA - Each	71610-865	d2f266a4-75ba-40fb-9a3b-6e08e1210ac9	1	2025-02-10
71610-865-60	EA - Each	71610-865	eb2b9bda-b688-4b43-8bb3-714aeb412006	1	2025-02-10
71610-865-65	EA - Each	71610-865	170dffb0-5aff-4858-bd9b-1fff77fceb84	1	2025-02-10
71610-865-67	EA - Each	71610-865	edfd9a73-a134-415b-8af9-1e71246c3aa5	1	2025-02-10
71610-865-70	EA - Each	71610-865	b833aae8-0fe8-4822-87cd-cca4fb2ae32f	1	2025-02-10
71610-865-72	EA - Each	71610-865	d85e4f33-b8a2-4b05-b9d1-2e73f7962f06	1	2025-02-10
71610-865-73	EA - Each	71610-865	45106ae6-d256-40e5-9179-190b3f74d533	1	2025-02-10
71610-865-75	EA - Each	71610-865	d2e1d318-6d0b-4bae-ac41-890dbff77874	1	2025-02-10
71610-865-80	EA - Each	71610-865	b24a90bb-f9e6-4d33-aeb0-659b9fc86b42	1	2025-02-10
71610-865-85	EA - Each	71610-865	747de44d-127d-4fc8-8de6-f90cc293078f	1	2025-02-10
71610-865-90	EA - Each	71610-865	ac6c9315-6773-4f43-8dbc-9f317fc38747	1	2025-02-10
71610-865-92	EA - Each	71610-865	2a35d9ae-4fcd-4e4f-a369-9e9f7e1aa8b1	1	2025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-865	TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]	1	Current NDC, 23 package rows	20241121_27460cc6-0782-7838-e063-6394a90a19f1.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Golden State Medical Supply, Inc.	24aea499-c6f1-9200-e063-6394a90a9db6	2026-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075977 application number: ANDA075977
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	561f00e5-f69c-4369-ae4d-5eff86c4499f	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075977 application number: ANDA075977
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	27460cc6-0782-7838-e063-6394a90a19f1	2024-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075977 application number: ANDA075977 ndc (package): 71610-865-80 ndc (product): 71610-865 ndc11 (package): 71610086580
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	bbd6c0d4-110c-4bda-9d9f-89ab7ce4c18e	2019-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075977 application number: ANDA075977

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	27460cc6-0782-7838-e063-6394a90a19f1	1
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	27460cc6-0782-7838-e063-6394a90a19f1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71610-865-80	71610086580	180 TABLET, FILM COATED in 1 BOTTLE (71610-865-80)	2024-11-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2024-11-18	HUMAN PRESCRIPTION DRUG LABEL	1