Vibramycin Monohydrate

Product NDC
0069-0970
11-digit product format
000690970
Labeler code
0069
Product ID
0069-0970_5414f42d-cfc3-465c-9aaf-d34adcb2626e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA050006
Marketing category
NDA
Marketing start
1967-12-06
Marketing end
0000-00-00
Substance
DOXYCYCLINE
Active strength
25 mg/5mL
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0069-0970DDiscontinued by firm2026-07-31
excluded packagepackage0069-09700069-0970-65DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N050006-001VIBRAMYCINDOXYCYCLINEEQ 25MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD, Approved before 1982

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
2026-08-01 22:54:322026-06N050006-001VIBRAMYCINEQ 25MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD, Approved before 1982a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0970-65ML - Milliliter0069-09702439a728-4088-43af-b016-0a681ac904e712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13OVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
DOXYCYCLINE CALCIUMACTIVE INGREDIENT8ZL07I20SBVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862VIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933VIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8VIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311VIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
GLYCERININACTIVE INGREDIENTPDC6A3C0OXVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
POVIDONESINACTIVE INGREDIENTFZ989GH94EVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
SORBITOLINACTIVE INGREDIENT506T60A25RVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
SUCROSEINACTIVE INGREDIENTC151H8M554VIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
TALCINACTIVE INGREDIENT7SEV7J4R1UVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20
WATERINACTIVE INGREDIENT059QF0KO0RVIBRAMYCIN MONOHYDRATE (DOXYCYCLINE) POWDER, FOR SUSPENSION VIBRAMYCIN CALCIUM (DOXYCYCLINE CALCIUM) SYRUP VIBRAMYCIN HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE VIBRA-TABS (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-0970-65000690970651 BOTTLE in 1 CARTON (0069-0970-65) > 60 mL in 1 BOTTLE1 bottle1967-12-060000-00-00NoNoCurrent