FDA.reportPublic FDA data

Proparacaine hydrochloride

Product NDC
70756-193
11-digit product format
707560193
Labeler code
70756
Product ID
70756-193_7d7eab12-f721-4092-8c18-7100544ade2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Proparacaine hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Lifestar Pharma LLC
Application
ANDA219136
Marketing category
ANDA
Marketing start
2025-05-21
Substance
PROPARACAINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Local Anesthesia [PE], Local Anesthetic [EPC]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219136-001PROPARACAINE HYDROCHLORIDEPROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2025-05-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219136-001AT

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A219136-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2025-05-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219136-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2025-05-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219136-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2025-05-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219136-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2025-05-216a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219136-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2025-05-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A219136-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219136-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219136-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219136-001AT16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219136-001AT1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Proparacaine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPARACAINE HYDROCHLORIDE5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U96OL57GOYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1191013Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3419104b-e847-492f-a541-a810a116c408Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9ba0893a-4390-4124-b66b-ffd4f2b29a0eProduct name220260305

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-193-35Proparacaine hydrochloride15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
70756-193-35Proparacaine hydrochloride1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-193-35ML - Milliliter70756-193a93a3c65-3ef0-460e-a869-13ec713d12a712025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-193PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [LIFESTAR PHARMA LLC]4Current NDC, 2 package rows20250524_3419104b-e847-492f-a541-a810a116c408.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Proparacaine hydrochloridePROPARACAINE HYDROCHLORIDELifestar Pharma LLC3419104b-e847-492f-a541-a810a116c4082025-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219136
application number: ANDA219136
ndc (product): 70756-193

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191013proparacaine HCl 0.5 % Ophthalmic SolutionPSN3419104b-e847-492f-a541-a810a116c4084
1191013proparacaine hydrochloride 5 MG/ML Ophthalmic SolutionSCD3419104b-e847-492f-a541-a810a116c4084
1191013proparacaine hydrochloride 0.5 % Ophthalmic SolutionSY3419104b-e847-492f-a541-a810a116c4084

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70756-193-35707560193351 BOTTLE, DROPPER in 1 CARTON (70756-193-35) / 15 mL in 1 BOTTLE, DROPPER2025-05-21NoNoCurrent