TRAMADOL HYDROCHLORIDE

Product NDC: 47335-537
11-digit product format: 473350537
Labeler code: 47335
Product ID: 47335-537_e080bc94-c122-41f3-8bda-0fb9318f8aa6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRAMADOL HYDROCHLORIDE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA091607
Marketing category: ANDA
Marketing start: 2011-12-30
Substance: TRAMADOL HYDROCHLORIDE
Active strength: 300 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A091607-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-30
A091607-002	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-30
A091607-003	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	2011-12-30

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091607-002	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091607-003	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2011-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091607-001	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	RS	2011-12-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091607-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091607-002	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091607-003	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091607-001	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091607-002	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091607-003	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091607-001	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091607-002	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091607-003	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091607-001	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091607-002	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091607-003	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091607-001	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091607-002	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091607-003	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091607-001	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091607-002	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091607-003	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091607-001	AB2	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091607-002	AB2	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091607-003	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091607-001	AB2	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091607-002	AB2	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091607-003	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091607-001	AB2	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091607-002	AB2	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091607-003	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091607-001	AB2	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091607-002	AB2	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091607-003	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091607-001	AB2	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091607-002	AB2	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091607-003	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091607-001	AB2	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091607-002	AB2	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091607-003	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091607-001	AB2	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091607-002	AB2	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091607-003	AB2	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091607-001	AB2	1	`a67488948f0b…`

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	300 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1946525	Internal RxNorm lookup
1946527	Internal RxNorm lookup
1946529	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
dc420d50-6192-482d-b3da-3be55870a79a	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
47335-537-08	TRAMADOL HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	28
47335-537-18	TRAMADOL HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	28
47335-537-83	TRAMADOL HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	28
47335-537-88	TRAMADOL HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-537-83	EA - Each	47335-537	7c05936d-bab8-4a83-9bfc-9e83a2074152	1	2012-07-24
47335-537-88	EA - Each	47335-537	ba39a918-7077-419e-94e6-c0aca54c59c0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRAMADOL HYDROCHLORIDE	ACTIVE INGREDIENT	9N7R477WCK	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
TRAMADOL	ACTIVE MOIETY	39J1LGJ30J	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-537	TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	24	Current NDC, Legacy NDC, 4 package rows	20240119_dc420d50-6192-482d-b3da-3be55870a79a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	dc420d50-6192-482d-b3da-3be55870a79a	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091607 application number: ANDA091607 ndc (product): 47335-537
Tramadol HCL ER	TRAMADOL HCL	Advanced Rx Pharmacy of Tennessee, LLC	bba287fe-fbf6-65a9-e053-2a95a90a9237	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091607 application number: ANDA091607

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
1946529	traMADol hydrochloride 100 MG Matrix Delivery 24HR Extended Release Oral Tablet	PSN	dc420d50-6192-482d-b3da-3be55870a79a	28
1946527	traMADol hydrochloride 200 MG Matrix Delivery 24HR Extended Release Oral Tablet	PSN	dc420d50-6192-482d-b3da-3be55870a79a	28
1946525	traMADol hydrochloride 300 MG Matrix Delivery 24HR Extended Release Oral Tablet	PSN	dc420d50-6192-482d-b3da-3be55870a79a	28
1946529	Matrix Delivery 24 HR tramadol hydrochloride 100 MG Extended Release Oral Tablet	SCD	dc420d50-6192-482d-b3da-3be55870a79a	28
1946527	Matrix Delivery 24 HR tramadol hydrochloride 200 MG Extended Release Oral Tablet	SCD	dc420d50-6192-482d-b3da-3be55870a79a	28
1946525	Matrix Delivery 24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet	SCD	dc420d50-6192-482d-b3da-3be55870a79a	28
1946529	tramadol hydrochloride 100 MG Matrix Delivery 24 HR Extended Release Oral Tablet	SY	dc420d50-6192-482d-b3da-3be55870a79a	28
1946527	tramadol hydrochloride 200 MG Matrix Delivery 24 HR Extended Release Oral Tablet	SY	dc420d50-6192-482d-b3da-3be55870a79a	28
1946525	tramadol hydrochloride 300 MG Matrix Delivery 24 HR Extended Release Oral Tablet	SY	dc420d50-6192-482d-b3da-3be55870a79a	28

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-537-08	47335053708	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-537-08)	2011-12-30	0000-00-00	No	No	Current
47335-537-18	47335053718	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-537-18)	2011-12-30	0000-00-00	No	No	Current
47335-537-83	47335053783	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-537-83)	2011-12-30	0000-00-00	No	No	Current
47335-537-88	47335053788	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-537-88)	2011-12-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride Extended-Release Tablets, USP C-IV Rx Only	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2025-12-05	Human Prescription Drug Label	28