NDC codes

FDA NDC Directory
Product NDC (as listed)51991-907Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51991-0907Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
51991-907-015199109070151991090701100 CAPSULE in 1 BOTTLE, PLASTIC (51991-907-01)Marketed from Jan 18, 2019
51991-907-055199109070551991090705500 CAPSULE in 1 BOTTLE, PLASTIC (51991-907-05)Marketed from Jan 18, 2019
51991-907-33519910907335199109073330 CAPSULE in 1 BOTTLE, PLASTIC (51991-907-33)Marketed from Jan 18, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Tetracycline Hydrochloride
Generic name (nonproprietary)
tetracycline hydrochloride
Active ingredients
Tetracycline hydrochloride — 500 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Breckenridge Pharmaceutical, Inc.NDC labeler code 51991
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210662
Marketing start
Listing expires
Other FDA classes
Tetracyclines (Chemical structure)
Identifiers
Product ID 51991-907_89897fdb-30b1-4625-9526-7fe813924413SPL ID 89897fdb-30b1-4625-9526-7fe813924413SPL set ID 00acf413-c5d2-4a54-9d0d-56266cbc9edcRxCUI 198250, 198252UNII P6R62377KVUPC 0351991906018
Pharmacologic class
Tetracycline-class Antimicrobial

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N451991090701 followed by a unit qualifier and the quantity

Package 51991-0907-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the condit…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51991-907

What is NDC 51991-907?
51991-907 is the product NDC for Tetracycline Hydrochloride, Tetracycline hydrochloride 500 mg/1 capsule, listed with the FDA by Breckenridge Pharmaceutical, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tetracycline Hydrochloride.
What is the active ingredient?
Tetracycline hydrochloride.
Who is the labeler?
Breckenridge Pharmaceutical, Inc., NDC labeler code 51991. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tetracycline Hydrochloride?
21 other product NDCs are listed under this name. See all Tetracycline Hydrochloride NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tetracycline Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Tetracycline HydrochlorideTetracycline hydrochloride 500 mg/1CapsuleOralPreferred Pharmaceuticals Inc. .68788-413468788-4134-03
Tetracycline HydrochlorideTetracycline hydrochloride 500 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-885368788-8853-03
tetracycline hydrochlorideTetracycline hydrochloride 250 mg/1CapsuleOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-01723155-0017-01
tetracycline hydrochlorideTetracycline hydrochloride 500 mg/1CapsuleOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-01823155-0018-01
Tetracycline HydrochlorideTetracycline hydrochloride 250 mg/1Tablet, Film coatedOralPharmaka Generics Inc.82644-08782644-0087-60
Tetracycline HydrochlorideTetracycline hydrochloride 500 mg/1Tablet, Film coatedOralPharmaka Generics Inc.82644-87082644-0870-60
Tetracycline HydrochlorideTetracycline hydrochloride 250 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-152260219-1522-01
Tetracycline HydrochlorideTetracycline hydrochloride 500 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC60219-152360219-1523-01
Tetracycline HydrochlorideTetracycline hydrochloride 250 mg/1CapsuleOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-76623155-0766-01
Tetracycline HydrochlorideTetracycline hydrochloride 500 mg/1CapsuleOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-76723155-0767-01

All 22 Tetracycline Hydrochloride NDCs

Other NDCs under ANDA 210662

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 210662
ProductStrengthForm · routeLabelerProduct NDC
Tetracycline HydrochlorideTetracycline hydrochloride 250 mg/1CapsuleOralBreckenridge Pharmaceutical, Inc.51991-906
Tetracycline HydrochlorideTetracycline hydrochloride 500 mg/1CapsuleOralBryant Ranch Prepack71335-2141
Tetracycline HydrochlorideTetracycline hydrochloride 250 mg/1CapsuleOralBryant Ranch Prepack71335-2415

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