Tramadol Hydrochloride
- Manufacturer
- Galephar Pharmaceutical Research Inc.
- Effective date
- 2020-01-22
- Label type
- BULK INGREDIENT
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:42:34
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
Principal Display Panel - Drum Label
GALEPHAR P.R. Inc.
NDC: 66277-252-04
GI-252 Tramadol ER 100 mg
(Tramadol Capsules)
Lot # XXXXX
Caution: For further process only
Exp. Date MMM YYYY
Maintain between 15°C • 30°C (59°F • 86°F)
Gross: Net: Container: of
Lock ID: By/on: /
Km 14.7 #100 Juncos Industrial Park
Juncos, Puerto Rico 00777-3878
Phone: (787) 713-0340 Fax: (787) 713-0344

Principal Display Panel - Pail label
Principal Display Panel - Box Label
Manufacturer:
GALEPHAR PHARMA RESEARCH INC
Juncos Industrial Park Road 198 Km 14.2
Juncos, Puerto Rico 00777
NDC: 66277-252-06
ULTRAGESIC 100 MG
5 CAPSULES
SHIPPERS OF 12 BOTTLES
QTY: 12 Serial#: 000000
LOT#: LLLLLLL
EXP. DATE: MMYYYY
STORE AT 15°C • 30°C (59°F • 86°F)
Country of Origin: Puerto Rico
P.O. Number: XXXX
GK-384

Principal Display Panel - Drum Label
GALEPHAR P.R. Inc.
NDC: 66277-322-01
GI-322 Tramadol ER 150 mg
(Tramadol Capsules)
Lot # XXXXX
Caution: For further process only
Exp. Date MMM YYYY
Maintain between 15°C • 30°C (59°F • 86°F)
Gross: Net: Container: of
Lock ID: By/on: /
km 14.7 #100 Juncos Industrial Park
Juncos, Puerto Rico 00777-3878
Phone: (787) 713-0340 Fax: (787) 713-0344

Principal Display Panel - Pail label
Principal Display Panel - Box Label
Manufacturer:
GALEPHAR PHARMA RESEARCH INC
Juncos Industrial Park Road 198 Km 14.2
Juncos, Puerto Rico 00777
NDC: 66277-322-04
ULTRAGESIC 150 MG
5 CAPSULES
SHIPPERS OF 12 BOTTLES
QTY: 12 Serial#: 000000
LOT#: LLLLLLL
EXP. DATE: MMYYYY
STORE AT 15°C • 30°C (59°F • 86°F)
Country of Origin: Puerto Rico
P.O. Number: XXXX
GK-385

Principal Display Panel - Drum Label
GALEPHAR P.R. Inc.
NDC: 66277-253-04
GI-253 Tramadol ER 200 mg
(Tramadol Capsules)
Lot # XXXXX
Caution: For further process only
Exp. Date MMM YYYY
Maintain between 15°C • 30°C (59°F • 86°F)
Gross: Net: Container: of
Lock ID: By/on: /
km 14.7 #100 Juncos Industrial Park
Juncos, Puerto Rico 00777-3878
Phone: (787) 713-0340 Fax: (787) 713-0344

Principal Display Panel - Pail label
Principal Display Panel - Box Label
Manufacturer:
GALEPHAR PHARMA RESEARCH INC
Juncos Industrial Park Road 198 Km 14.2
Juncos, Puerto Rico 00777
NDC: 66277-253-06
ULTRAGESIC 200 MG
5 CAPSULES
SHIPPERS OF 12 BOTTLES
QTY: 12 Serial#: 000000
LOT#: LLLLLLL
EXP. DATE: MMYYYY
STORE AT 15°C • 30°C (59°F • 86°F)
Country of Origin: Puerto Rico
P.O. Number: XXXX
GK-386

Principal Display Panel - Drum Label
GALEPHAR P.R. Inc.
NDC: 66277-254-04
GI-254 Tramadol ER 300 mg
(Tramadol Capsules)
Lot # XXXXX
Caution: For further process only
Exp. Date MMM YYYY
Maintain between 15°C • 30°C (59°F • 86°F)
Gross: Net: Container: of
Lock ID: By/on: /
km 14.7 #100 Juncos Industrial Park
Juncos, Puerto Rico 00777-3878
Phone: (787) 713-0340 Fax: (787) 713-0344

Principal Display Panel - Pail label
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| TRAMADOL HYDROCHLORIDE | ACTIVE INGREDIENT | 9N7R477WCK | 1 | |
| TRAMADOL | ACTIVE MOIETY | 39J1LGJ30J | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| D&C RED NO. 7 | INACTIVE INGREDIENT | ECW0LZ41X8 | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) | INACTIVE INGREDIENT | P2OM2Q86BI | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| SUCROSE STEARATE | INACTIVE INGREDIENT | 274KW0O50M | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- Tramadol Hydrochloride Extended Release
- tramadol hydrochloride
- TRAMADOL
- GELATIN
- TITANIUM DIOXIDE
- SHELLAC
- FD&C BLUE NO. 2
- LACTOSE MONOHYDRATE
- CELLULOSE, MICROCRYSTALLINE
- SUCROSE STEARATE
- POVIDONE K30
- STARCH, CORN
- MAGNESIUM STEARATE
- HYPROMELLOSE 2910 (6 MPA.S)
- TALC
- POLYSORBATE 80
- ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)
- FERRIC OXIDE YELLOW
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- SILICON DIOXIDE
- D&C RED NO. 7
- D&C YELLOW NO. 10
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66277-252 | 66277-252-04, 66277-252-05, 66277-252-06 |
| 66277-322 | 66277-322-01, 66277-322-02, 66277-322-04 |
| 66277-253 | 66277-253-04, 66277-253-05, 66277-253-06 |
| 66277-254 | 66277-254-04, 66277-254-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / BUCCAL | 43 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, LIQUID FILLED / ORAL | 1.51 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, COATED / ORAL | 300 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SHAMPOO / TOPICAL | NA | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | 174 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / VAGINAL | 28 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | LIQUID / INTRAVENOUS | 720 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | FILM / BUCCAL | 0.27 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | GEL / TOPICAL | 12 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, EXTENDED RELEASE / ORAL | 10 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / RECTAL | 72.15 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, COATED / ORAL | 1301 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION/ DROPS / OPHTHALMIC | 0.25 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, EXTENDED RELEASE / ORAL | 2575 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, EXTENDED RELEASE / ORAL | 5364 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | PELLET / ORAL | 640 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) | ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) | P2OM2Q86BI | CAPSULE, EXTENDED RELEASE / ORAL | 187.3 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| GELATIN | GELATIN | 2G86QN327L | GUM, CHEWING / BUCCAL | 102 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, COATED PELLETS / ORAL | 265 mg | ||
| TALC | TALC | 7SEV7J4R1U | POWDER, FOR SUSPENSION / ORAL | 735 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, DELAYED RELEASE / ORAL | 525 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GEL / RECTAL | 348 mg | ||
| HYPROMELLOSE 2910 (6 MPA.S) | HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | TABLET, DELAYED RELEASE / ORAL | 77 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, COATED / ORAL | 24.12 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | CAPSULE / ORAL | 4 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET / ORAL | 25 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | TABLET, DELAYED RELEASE / ORAL | 8 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED / ORAL | 288 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, SUGAR COATED / ORAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CONCENTRATE / ORAL | 1 mg/1ml | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, EXTENDED RELEASE / ORAL | 14 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, EXTENDED RELEASE / ORAL | 1229 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| D&C RED NO. 7 | D&C RED NO. 7 | ECW0LZ41X8 | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRAVITREAL | 0.02 %w/v | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| tramadol hydrochloride | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | c6104e62-5b2c-41a1-afb3-00dcf267a384 | 2026-09-01 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| tramadol hydrochloride | TRAMADOL HYDROCHLORIDE | Strides Pharma Science Limited | a6cbd5de-8ae5-49e3-b89b-e35536b115d8 | 2026-08-27 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Aurobindo Pharma Limited | e5005d9e-91cb-4ff8-bcf2-b5ee70cf4f3f | 2026-08-25 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | 16053b28-c759-4914-93e6-2de0afe72445 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 42de8c3a-0441-5d46-e063-6294a90a2079 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | 6bb5be12-59ff-40f4-9841-9c7ab93be2ea | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 552e5b32-accf-29dd-e063-6294a90a4fcf | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Northwind Health Company, LLC | 552955e6-2bb3-8755-e063-6394a90ab21c | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Coupler LLC | 54d74939-301b-e603-e063-6394a90a3b03 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 515baa9a-b226-4bbe-be87-f9befdf1c9e1 | 2026-06-18 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | 5199132e-745e-46a0-8068-e06d1bca5c61 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 855905c7-1481-4b2d-a318-3254ad8ed73c | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | aefc85bc-0820-4aee-8d94-313c5f1658f5 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Major Pharmaceuticals | 6b0b95b2-ae4c-42e8-9f2e-bcdaffda62e2 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 66359f41-9999-4cb8-b632-1fe2ec1e60b2 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 43fe10b2-17a4-4dc2-9a48-2378547b61fd | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | f2f421ab-35ae-7637-e053-2995a90a40e0 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 674803a0-4cf5-4416-a5e3-c1a1e332cdcd | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | acd5d8e0-a4cc-4654-ae04-faff347a60ca | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | 007bf37f-0e46-426a-ac8c-be63d4b7414c | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.



