Prescription drug · ANDA

Ketorolac Tromethamine NDC 63629-2974

Ketorolac tromethamine 10 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)63629-2974Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-2974Add 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
63629-2974-063629297400636292974003 TABLET, FILM COATED in 1 BOTTLE (63629-2974-0)Marketed from May 9, 2011
63629-2974-1636292974016362929740130 TABLET, FILM COATED in 1 BOTTLE (63629-2974-1)Marketed from Apr 3, 2009
63629-2974-2636292974026362929740210 TABLET, FILM COATED in 1 BOTTLE (63629-2974-2)Marketed from Mar 9, 2006
63629-2974-3636292974036362929740320 TABLET, FILM COATED in 1 BOTTLE (63629-2974-3)Marketed from Apr 3, 2009
63629-2974-4636292974046362929740490 TABLET, FILM COATED in 1 BOTTLE (63629-2974-4)Marketed from Oct 9, 2014
63629-2974-5636292974056362929740516 TABLET, FILM COATED in 1 BOTTLE (63629-2974-5)Marketed from Mar 23, 2012
63629-2974-663629297406636292974068 TABLET, FILM COATED in 1 BOTTLE (63629-2974-6)Marketed from Mar 31, 2014
63629-2974-7636292974076362929740715 TABLET, FILM COATED in 1 BOTTLE (63629-2974-7)Marketed from Feb 11, 2010
63629-2974-863629297408636292974085 TABLET, FILM COATED in 1 BOTTLE (63629-2974-8)Marketed from Apr 11, 2011
63629-2974-96362929740963629297409100 TABLET, FILM COATED in 1 BOTTLE (63629-2974-9)Marketed from Dec 22, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Ketorolac Tromethamine
Generic name (nonproprietary)
ketorolac tromethamine
Active ingredients
Ketorolac tromethamine — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074754
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 63629-2974_1d9caf46-330d-433f-962e-8da0468be79eSPL ID 1d9caf46-330d-433f-962e-8da0468be79eSPL set ID f713500a-20b8-8e20-c4cc-956805170335RxCUI 834022UNII 4EVE5946BQ
Pharmacologic class
Cyclooxygenase Inhibitor; Nonsteroidal Anti-inflammatory Drug

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

N463629297400 followed by a unit qualifier and the quantity

Package 63629-2974-00. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ketorolac tromethamine tablets, USP and other treatment options before deciding to use ketorolac tromethamine tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult Patients Ketorolac tromethamine tablets, USP are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets, USP are to be used only as continuation …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-2974

What is NDC 63629-2974?
63629-2974 is the product NDC for Ketorolac Tromethamine, Ketorolac tromethamine 10 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ketorolac Tromethamine.
What is the active ingredient?
Ketorolac tromethamine.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ketorolac Tromethamine?
183 other product NDCs are listed under this name. See all Ketorolac Tromethamine 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 Ketorolac Tromethamine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ketorolac TromethamineKetorolac tromethamine 60 mg/2mLInjection, SolutionIntramuscularAnthea Pharma Private Limited83854-02483854-0024-25
Ketorolac TromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscular, IntravenousAnthea Pharma Private Limited83854-02283854-0022-25
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralAmerisyn LLC87564-01887564-0018-10
ketorolac tromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-412968788-4129-0268788-4129-03
Ketorolac TromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscularBaxter Healthcare Corporation43066-05343066-0053-10
Ketorolac TromethamineKetorolac tromethamine 15 mg/mLInjection, SolutionIntramuscular, IntravenousBaxter Healthcare Corporation43066-04943066-0049-10
Ketorolac TromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscular, IntravenousBaxter Healthcare Corporation43066-05143066-0051-10
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralInjecta Medcial LLC87234-769587234-7695-02
Ketorolac TromethamineKetorolac tromethamine 30 mg/mLInjection, SolutionIntramuscular, IntravenousCardinal Health 107, LLC55154-783355154-7833-05
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralInjecta Medcial LLC87234-769587234-7695-01

All 184 Ketorolac Tromethamine NDCs

Other NDCs under ANDA 074754

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

FDA NDC Directory listings under ANDA 074754
ProductStrengthForm · routeLabelerProduct NDC
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-0314
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-904
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-0601
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-170
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-104
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralProficient Rx LP63187-128
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.66267-418
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.66267-832
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0048
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-032
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0139
Ketorolac TromethamineKetorolac tromethamine 10 mg/1Tablet, Film coatedOralSportpharm LLC85766-035

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