TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product NDC: 42571-119
11-digit product format: 425710119
Labeler code: 42571
Product ID: 42571-119_46978b2e-ad09-e4f1-e063-6394a90a5208
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Micro Labs Limited
Application: ANDA201952
Marketing category: ANDA
Marketing start: 2012-12-15
Substance: ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Active strength: 325; 37.5 mg/1; 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

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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42571-119		D	Discontinued by firm	2026-08-17
excluded package	package	42571-119	42571-119-01	D	Discontinued by firm	2026-08-17
excluded package	package	42571-119	42571-119-05	D	Discontinued by firm	2026-08-17
excluded package	package	42571-119	42571-119-23	D	Discontinued by firm	2026-08-17
excluded package	package	42571-119	42571-119-90	D	Discontinued by firm	2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	325MG;37.5MG	TABLET / ORAL			2012-12-14

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 · 42 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
2026-08-18 06:07:40	2026-07	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2012-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201952-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201952-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201952-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201952-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201952-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201952-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201952-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201952-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201952-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201952-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201952-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201952-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201952-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201952-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201952-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201952-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201952-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201952-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201952-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201952-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201952-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201952-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201952-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201952-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201952-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201952-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201952-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201952-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201952-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201952-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201952-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201952-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201952-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201952-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201952-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201952-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201952-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201952-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201952-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201952-001	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42571-119-01	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	100 in 1 BOTTLE	TABLET, FILM COATED	100	28
42571-119-05	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	500 in 1 BOTTLE	TABLET, FILM COATED	500	28
42571-119-23	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	8 in 1 CARTON	TABLET, FILM COATED	8	28
42571-119-32	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	28
42571-119-90	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	90 in 1 BOTTLE	TABLET, FILM COATED	90	28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-119-01	EA - Each	42571-119	ca1cbd33-5f32-41c4-bab7-ead0ef80c663	1	2013-07-02
42571-119-05	EA - Each	42571-119	fd47a9a1-7410-425d-a3ef-442d09d7f58c	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]	15
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]	15
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]	15
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]	15
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]	15
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]	15
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]	15
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]	15
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]	15
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]	15
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MICRO LABS LIMITED]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-119	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, FILM COATED [MICRO LABS LIMITED]	27	Current NDC, Legacy NDC, 5 package rows	20231228_ab84058e-e52c-4b81-badc-4b0c26aab259.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 AND ACETAMINOPHEN	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Asclemed USA, Inc.	82d8b70f-aebf-4b9a-89b1-183fc9e2ff59	2020-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201952 application number: ANDA201952

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9N7R477WCK	TRAMADOL HYDROCHLORIDE	36282-47-0	TRAMADOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
836395	traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet	PSN	ab84058e-e52c-4b81-badc-4b0c26aab259	28
836395	acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SCD	ab84058e-e52c-4b81-badc-4b0c26aab259	28
836395	APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SY	ab84058e-e52c-4b81-badc-4b0c26aab259	28
836395	traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet	PSN	82d8b70f-aebf-4b9a-89b1-183fc9e2ff59	1
836395	acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SCD	82d8b70f-aebf-4b9a-89b1-183fc9e2ff59	1
836395	APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet	SY	82d8b70f-aebf-4b9a-89b1-183fc9e2ff59	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42571-119-01	42571011901	100 TABLET, FILM COATED in 1 BOTTLE (42571-119-01)		2012-12-15	0000-00-00	No	No	Current
42571-119-05	42571011905	500 TABLET, FILM COATED in 1 BOTTLE (42571-119-05)		2012-12-15	0000-00-00	No	No	Current
42571-119-23	42571011923	8 BLISTER PACK in 1 CARTON (42571-119-23) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-119-32)	8 blister pack	2012-12-15	0000-00-00	No	No	Current
42571-119-32	42571011932	10 in 1 BLISTER PACK						Historical
42571-119-90	42571011990	90 TABLET, FILM COATED in 1 BOTTLE (42571-119-90)		2012-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Micro Labs Limited	2025-12-22	HUMAN PRESCRIPTION DRUG LABEL	28
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	REMEDYREPACK INC.	2022-02-02	HUMAN PRESCRIPTION DRUG LABEL	3
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Preferred Pharmaceuticals, Inc.	2021-09-21	HUMAN PRESCRIPTION DRUG LABEL	2
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2020-10-30	HUMAN PRESCRIPTION DRUG LABEL	1