Tramadol Hydrochloride

Product NDC: 63187-063
11-digit product format: 631870063
Labeler code: 63187
Product ID: 63187-063_59d339c1-6ad2-4407-ac41-74e5f4dda6e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA076003
Marketing category: ANDA
Marketing start: 2010-11-15
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 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
A076003-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076003-001	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	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`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	A076003-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076003-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076003-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076003-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076003-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076003-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076003-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076003-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076003-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076003-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076003-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076003-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076003-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076003-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076003-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076003-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076003-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076003-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076003-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076003-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076003-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076003-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076003-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076003-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076003-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076003-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076003-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076003-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076003-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076003-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076003-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076003-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076003-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076003-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076003-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076003-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076003-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076003-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076003-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076003-001	AB	1	`cb3db0bc1861…`

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
50f4b752-20af-4ebf-9408-e78f30d2a3cc	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
63187-063-15	Tramadol Hydrochloride	15 in 1 BOTTLE	TABLET, COATED	15	7
63187-063-20	Tramadol Hydrochloride	20 in 1 BOTTLE	TABLET, COATED	20	7
63187-063-30	Tramadol Hydrochloride	30 in 1 BOTTLE	TABLET, COATED	30	7
63187-063-40	Tramadol Hydrochloride	40 in 1 BOTTLE	TABLET, COATED	40	7
63187-063-60	Tramadol Hydrochloride	60 in 1 BOTTLE	TABLET, COATED	60	7
63187-063-64	Tramadol Hydrochloride	240 in 1 BOTTLE	TABLET, COATED	240	7
63187-063-72	Tramadol Hydrochloride	120 in 1 BOTTLE	TABLET, COATED	120	7
63187-063-78	Tramadol Hydrochloride	180 in 1 BOTTLE	TABLET, COATED	180	7
63187-063-90	Tramadol Hydrochloride	90 in 1 BOTTLE	TABLET, COATED	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-063-15	EA - Each	63187-063	6c75e825-7dc1-41e1-8b73-9dc25e8987ea	1	2017-11-06
63187-063-20	EA - Each	63187-063	32e0ce37-1e0f-47ab-8c55-b57cbca66802	1	2017-07-07
63187-063-30	EA - Each	63187-063	975b5f42-0e9e-499d-aa02-edf1bd6f23a4	1	2016-04-04
63187-063-60	EA - Each	63187-063	02aa5934-4b2c-42ea-83cd-92105d1b253f	1	2015-10-02
63187-063-72	EA - Each	63187-063	b202e080-8888-47b5-8519-2373eab67c9d	1	2016-10-06
63187-063-78	EA - Each	63187-063	a089ea55-ac49-44bc-92e6-030182720aa1	1	2016-10-06
63187-063-90	EA - Each	63187-063	c6cc3dfc-02c4-4596-a781-f2016af3c595	1	2016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]	2
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-063	TRAMADOL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]	7	Current NDC, Legacy NDC, 9 package rows	20191121_50f4b752-20af-4ebf-9408-e78f30d2a3cc.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Coupler LLC	54d74939-301b-e603-e063-6394a90a3b03	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Major Pharmaceuticals	6b0b95b2-ae4c-42e8-9f2e-bcdaffda62e2	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	67919c2c-2f8a-4bbb-bef5-0cd6c1e63a16	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	8ec4e4e5-a56e-4198-8428-6b770b9bf27d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	American Health Packaging	f6f6069b-cc75-4b87-afa5-b83001b543e0	2025-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2e738ced-9cde-e776-e063-6294a90a7e33	2025-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Clinical Solutions Wholesale, LLC	728157e2-d153-4ea0-81eb-36599dc7dfda	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5babcfcf-331b-5db9-e053-2a91aa0aaf89	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol HCL	TRAMADOL HCL	Advanced Rx of Tennessee, LLC	af87fc31-07c2-b1f7-e053-2995a90a499f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals LLC	58b802cb-2443-4f5b-9718-7d54c6d50cb4	2021-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	50f4b752-20af-4ebf-9408-e78f30d2a3cc	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003 ndc (product): 63187-063

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	50f4b752-20af-4ebf-9408-e78f30d2a3cc	7
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	50f4b752-20af-4ebf-9408-e78f30d2a3cc	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-063-15	63187006315	15 TABLET, COATED in 1 BOTTLE (63187-063-15)	2017-08-01	0000-00-00	No	No	Current
63187-063-20	63187006320	20 TABLET, COATED in 1 BOTTLE (63187-063-20)	2016-11-01	0000-00-00	No	No	Current
63187-063-30	63187006330	30 TABLET, COATED in 1 BOTTLE (63187-063-30)	2014-05-01	0000-00-00	No	No	Current
63187-063-40	63187006340	40 TABLET, COATED in 1 BOTTLE (63187-063-40)	2014-05-01	0000-00-00	No	No	Current
63187-063-60	63187006360	60 TABLET, COATED in 1 BOTTLE (63187-063-60)	2014-05-01	0000-00-00	No	No	Current
63187-063-64	63187006364	240 TABLET, COATED in 1 BOTTLE (63187-063-64)	2014-05-01	0000-00-00	No	No	Current
63187-063-72	63187006372	120 TABLET, COATED in 1 BOTTLE (63187-063-72)	2014-05-01	0000-00-00	No	No	Current
63187-063-78	63187006378	180 TABLET, COATED in 1 BOTTLE (63187-063-78)	2014-05-01	0000-00-00	No	No	Current
63187-063-90	63187006390	90 TABLET, COATED in 1 BOTTLE (63187-063-90)	2014-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride C-IV Tablets, USP	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	7