FDA.reportPublic FDA data

Tetracaine

Product NDC
63629-9160
11-digit product format
636299160
Labeler code
63629
Product ID
63629-9160_eef5b4a6-01c5-4d60-a68b-ecdf37a00473
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TETRACAINE HYDROCHLORIDE
Dosage form
INJECTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-07-20
Marketing end
0000-00-00
Substance
TETRACAINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-9160DDiscontinued by firm2026-08-11
excluded packagepackage63629-916063629-9160-1DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-9160-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-9160-1f5e01cc5f278…a2eaf40c39c3…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9160-1ML - Milliliter63629-9160355c5222-fe51-4a5e-bfac-0b2ae66885b512022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9160TETRACAINE (TETRACAINE HYDROCHLORIDE) INJECTION [BRYANT RANCH PREPACK]102Legacy NDC20240113_fd45e843-e5ee-4fd7-b11d-108fb76d9d96.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9160-16362991600110 VIAL in 1 BOX (63629-9160-1) > 2 mL in 1 VIAL10 vial2022-02-020000-00-00NoNoCurrent