Bupivacaine Hydrochloride

Product NDC
55150-167
11-digit product format
551500167
Labeler code
55150
Product ID
55150-167_39649703-e633-4a20-ba71-0c04dbf8ff2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL
Labeler
Eugia US LLC
Application
ANDA203895
Marketing category
ANDA
Marketing start
2013-11-05
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
2.5 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
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 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2013-11-05
A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2013-11-05
A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE / INJECTIONAP2013-11-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A203895-001AP
A203895-002AP
A203895-003AP

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203895-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2013-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203895-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2013-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203895-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2013-11-051e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203895-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203895-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A203895-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203895-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203895-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203895-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203895-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203895-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203895-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203895-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203895-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203895-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203895-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203895-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203895-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203895-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203895-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203895-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203895-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203895-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203895-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203895-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203895-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203895-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203895-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203895-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203895-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203895-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203895-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203895-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203895-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203895-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203895-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203895-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203895-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203895-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203895-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203895-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203895-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203895-001AP11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Bupivacaine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7TQO7W3VT8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012396Internal RxNorm lookup
1012404Internal RxNorm lookup
1724786Internal RxNorm lookup
1724787Internal RxNorm lookup
1724880Internal RxNorm lookup
1724884Internal RxNorm lookup
1725078Internal RxNorm lookup
1725082Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ffecf450-1f01-4721-8e10-251385852612Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-167-10Bupivacaine Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION109
55150-167-10Bupivacaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-167-10ML - Milliliter55150-167424049ac-1a0e-47c0-b8e0-5faf78124dae12014-01-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-167BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]9Current NDC, Legacy NDC, 2 package rows20250516_ffecf450-1f01-4721-8e10-251385852612.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEEugia US LLCffecf450-1f01-4721-8e10-2513858526122025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203895
application number: ANDA203895
ndc (product): 55150-167
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEAsclemed USA, Inc.a60303c2-5217-41db-855b-83fa2a749da22022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203895
application number: ANDA203895
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEAsclemed USA, Inc.3eefbefe-78ae-4f2d-9be6-3f79eadcff862020-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203895
application number: ANDA203895

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSNffecf450-1f01-4721-8e10-2513858526129
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSNffecf450-1f01-4721-8e10-2513858526129
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSNffecf450-1f01-4721-8e10-2513858526129
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSNffecf450-1f01-4721-8e10-2513858526129
1724884BUPivacaine HCl 0.5 % in 30 ML InjectionPSNffecf450-1f01-4721-8e10-2513858526129
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSNffecf450-1f01-4721-8e10-2513858526129
1724787BUPivacaine HCl 0.75 % in 10 ML InjectionPSNffecf450-1f01-4721-8e10-2513858526129
1724786BUPivacaine HCl 0.75 % in 30 ML InjectionPSNffecf450-1f01-4721-8e10-2513858526129
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDffecf450-1f01-4721-8e10-2513858526129
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCDffecf450-1f01-4721-8e10-2513858526129
172478710 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCDffecf450-1f01-4721-8e10-2513858526129
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDffecf450-1f01-4721-8e10-2513858526129
172488430 ML bupivacaine hydrochloride 5 MG/ML InjectionSCDffecf450-1f01-4721-8e10-2513858526129
172478630 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCDffecf450-1f01-4721-8e10-2513858526129
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCDffecf450-1f01-4721-8e10-2513858526129
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCDffecf450-1f01-4721-8e10-2513858526129
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSYffecf450-1f01-4721-8e10-2513858526129
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSYffecf450-1f01-4721-8e10-2513858526129
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSYffecf450-1f01-4721-8e10-2513858526129
1724884bupivacaine HCl 0.5 % in 30 ML InjectionSYffecf450-1f01-4721-8e10-2513858526129
1724787bupivacaine HCl 0.75 % in 10 ML InjectionSYffecf450-1f01-4721-8e10-2513858526129
1724786bupivacaine HCl 0.75 % in 30 ML InjectionSYffecf450-1f01-4721-8e10-2513858526129
1724786bupivacaine HCl 225 MG per 30 ML InjectionSYffecf450-1f01-4721-8e10-2513858526129
1724787bupivacaine HCl 75 MG per 10 ML InjectionSYffecf450-1f01-4721-8e10-2513858526129
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSYffecf450-1f01-4721-8e10-2513858526129
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSYffecf450-1f01-4721-8e10-2513858526129
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN3eefbefe-78ae-4f2d-9be6-3f79eadcff861
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD3eefbefe-78ae-4f2d-9be6-3f79eadcff861
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSY3eefbefe-78ae-4f2d-9be6-3f79eadcff861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-167-105515001671025 VIAL, SINGLE-DOSE in 1 CARTON (55150-167-10) / 10 mL in 1 VIAL, SINGLE-DOSE2013-11-050000-00-00NoNoCurrent